From foodconsumer.org
Medical Product Safety Network Newsletter #24, May 2008
By FDA
Apr 30, 2008 - 2:53:52 PM
Medical Product Safety Network
Highlighted articles include:
Important Notice to Manufacturers and Initial Distributors of Medical Devices That May Contain Heparin Or Are Heparin-Coated
MedSun reporters and other healthcare facilities can still submit heparin reports to MedSun or MedWatch, and they will be directed to the attention of FDA’s Center for Drug Evaluation and Research (CDER)…
FDA Makes Recommendations on Medical Devices That Treat Blocked Heart Arteries
Draft guidelines have been issued by FDA to aid the development, testing and manufacture of coronary drug-eluting stents, and devices used to treat blocked heart arteries…
Preventing Accidents and Injuries in the MRI Suite
This article provides risk reduction strategies and Joint Commission recommendations to reduce MRI accidents, injuries, and deaths…
Alarm Interventions during Medical Telemetry Monitoring: A Failure Mode & Effects Analysis
Healthcare facilities can use the published results of the failure mode and effects analysis to understand telemetry monitoring alarm response processes and as an aid to develop facility-specific risk reduction strategies…
Preventing the Retention of Foreign Objects during Interventional Radiology Procedures
The article provides recommendations and safe practices to help prevent the retention of foreign objects during interventional radiology (IR) procedures. This includes the use of sponge, sharp and instrument counts in IR to prevent the risk of serious patient harm related to the retention of foreign objects in this setting…
Low Frequency Magnetic Emissions and Resulting Induced Voltages in a Pacemaker by iPod Portable Music Players
Based on the observations of an in-vitro study, researchers concluded that no interference effects occurred in pacemakers exposed to the tested iPod devices…
FDA's Office of In Vitro Diagnostics Has Approved the Following New Devices for Marketing:
Dako TOP2A FISH pharmDx™ Kit is a laboratory test used to help a doctor assess the likely clinical course for certain patients with breast cancer. The test uses fluorescent DNA probes to measure the number of copies of the TOP2A (Topoisomerase 2 alpha) gene on chromosome 17 in breast cancer cells...
Articles
Important Notice to Manufacturers and Initial Distributors of Medical Devices That May Contain Heparin Or Are Heparin-Coated |
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The recent serious injuries and deaths associated with the use of
potentially contaminated heparin are very much in focus at this time.
To the MedSun Community: Your reports submitted to MedSun are key to
MedSun's success in helping FDA and the manufacturers ensure the safety
of medical devices, tissues, cells, and related products, so please
report the problems you see. The information from incoming reports
shared through MedSun News and the de-identified versions of the
reports contributed to FDA’s public database benefit health care
facilities and researchers throughout the Nation. You may still report
these heparin issues though the MedSun system and rest assure they will
be directed to the attention of the Center for Drug Evaluation and
Research (CDER).
Please visit http://www.fda.gov/cdrh/safety/heparin-notice.html for additional information.
Additional Information:
Important
Notice to Manufacturers and Initial Distributors of Medical Devices
That May Contain Heparin Or Are Heparin-Coated. FDA Website. April 8,
2008.
http://www.fda.gov/cdrh/safety/heparin-notice.html
FDA Press Release
U.S. Food and Drug Administration
Commissioner Andrew C. von Eschenbach announced that the agency has
issued draft guidelines to aid the development, testing and manufacture
of coronary drug-eluting stents, devices used to treat blocked heart
arteries.
Over the past few years, FDA and the clinical
community have been closely monitoring these devices, including
concerns over clot formation in some patients several years after
implantation. The draft guidelines issued today—called an FDA guidance
document—outline the agency's recommendations for pre-market clinical
evaluation and post-market studies, which may provide data to better
address this and other potential safety concerns.
Each year in
the United States, approximately one million patients undergo
procedures to treat coronary atherosclerosis, also known as hardening
or blockages of the heart arteries, a condition that can cause angina
and heart attacks.
Some 650,000 of these patients are treated
with drug-eluting stents, a scaffolding device that is placed into the
arteries to prop them open. Drug-eluting stents have a coating that
slowly releases a drug to prevent the growth of scar tissue that may
accumulate after the initial procedure opens the artery.
Re-accumulation of scar tissue can mean additional procedures to keep
arteries open and preserve adequate blood flow.
"This draft
guidance is part of FDA's ongoing effort to provide regulated industry
with recommendations on measures that can minimize the risks while
preserving for patients the benefits of drug-eluting stents," said
Daniel G. Schultz, M.D., director of FDA's Center for Devices and
Radiological Health.
This draft guidance, announced in the
Federal Register, http://www.gpoaccess.gov/fr/index.html, discusses the
development pathway for new drug-eluting stents and provides
recommendations on information necessary for a complete marketing
submission. It also provides guidance on assessing the toxicity of the
drug used to coat the stent, both on its own and as part of the
complete product. Because these stents combine device and drug
technology, this guidance contains expertise and input from two agency
centers—the Center for Devices and Radiological Health and the Center
for Drug Evaluation and Research.
Also included are draft
recommendations for engineering tests, biocompatibility tests, and
animal studies to assess the device's overall safety.
"This
guidance demonstrates how FDA will need to work across traditional
product boundaries to guide the development of innovative new
products," said Janet Woodcock, M.D., director of FDA's Center for Drug
Evaluation and Research.
Currently, FDA has approved three coronary drug-eluting stents.
A
copy of the guidance, "Draft Guidance for Industry on Developing
Coronary Drug Eluting Stents," can be found at
http://www.fda.gov/cdrh/ode/guidance/6255.html.
FDA is planning
a public workshop on drug-eluting stents, in part as one means of
soliciting comments on this guidance. The date, location and method for
comment for this workshop will be announced in the Federal Register and
on FDA's Web site, www.fda.gov.
FDA invites public comment on this draft guidance for 120 days from today's publication in the Federal Register.
Typed comments should include the docket number (CD6255), and be sent to:
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
To submit comments via the Internet, go to:
http://www.regulations.gov/search/index.jsp
Type in the docket number (CD6255), and follow instructions for comment submission.
Additional Information:
FDA Makes Recommendations on Medical Devices That Treat Blocked Heart Arteries. FDA Press Release. March 26, 2008.
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01810.html
The Federal Register (FR) Main Page is available at:
http://www.gpoaccess.gov/fr/index.html
To submit comments via the Internet, type in the docket number CD6255 at:
http://www.regulations.gov/search/index.jsp
© The Joint Commission, 2008.
While the capabilities of
the MRI scanner are well-recognized, its inherent dangers may not be as
well known. Injuries and deaths can and have occurred in the MRI suite.
The article provides risk reduction strategies and Joint Commission
recommendations to reduce MRI accidents.
Additional Information:
Preventing Accidents and Injuries in the MRI Suite. The Joint Commission. Issue 13. February 14, 2008.
http://www.jointcommission.org/SentinelEvents/SentinelEventAlert/sea_38.htm
Alarm Interventions during Medical Telemetry Monitoring: A Failure Mode & Effects Analysis |
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Pennsylvania Patient Safety Authority
Summary: Between
June 2004 and October 2006, PA-PSRS received 277 reports related to
alarm response during medical telemetry monitoring. All of the reports
described events in which patients were not consistently monitored for
physiologic conditions, and three events resulted in patient death.
PA-PSRS analysts conducted a failure mode and effects analysis (FMEA)
on alarm interventions during medical telemetry because of the
potential for serious patient harm or death. Healthcare facilities can
use the published results of this FMEA to understand telemetry
monitoring alarm response processes and similar process failures and as
an aid to develop facility-specific risk reduction strategies.
Additional Information:
Alarm
Interventions during Medical Telemetry Monitoring: A Failure Mode &
Effects Analysis. Pennsylvania Patient Safety Authority. March 2008.
http://www.psa.state.pa.us/psa/lib/psa/advisories/v5n1march_2008/mar_2008_medical_telemetry_fmea_supplementary_review.pdf
Preventing the Retention of Foreign Objects during Interventional Radiology Procedures |
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Pennsylvania Patient Safety Authority
The article
provides recommendations and safe practices to help prevent the
retention of foreign objects during interventional radiology (IR)
procedures. Facilities policies should routinely include the use of
sponge, sharp and instrument counts in IR to prevent the risk of
serious patient harm related to the retention of foreign objects in
this setting.
Additional Information:
Preventing
the Retention of Foreign Objects during Interventional Radiology
Procedures. Pennsylvania Patient Safety Authority. March 2008.
http://www.psa.state.pa.us/psa/lib/psa/advisories/v5n1march_2008/mar_2008_v5_n1_article_foreign_objects_interventional_radiology.pdf
Low Frequency Magnetic Emissions and Resulting Induced Voltages in a Pacemaker by iPod Portable Music Players
By Howard Bassen (FDA)
BioMedical Engineering OnLine. February 2008, Volume 7.
Abstract
Background
Recently,
malfunctioning of a cardiac pacemaker electromagnetic, caused by
electromagnetic interference (EMI) by fields emitted by personal
portable music players was highly publicized around the world. A
clinical study of one patient was performed and two types of
interference were observed when the clinicians placed a pacemaker
programming head and an iPod were placed adjacent to the patient's
implanted pacemaker. The authors concluded that "Warning labels may be
needed to avoid close contact between pacemakers and iPods". We
performed an in-vitro study to evaluate these claims of EMI and present
our findings of no-effects" in this paper.
Methods
We
performed in-vitro evaluations of the low frequency magnetic field
emissions from various models of the Apple Inc. iPod music player. We
measured magnetic field emissions with a 3-coil sensor (diameter of 3.5
cm) placed within 1 cm of the surface of the player. Highly localized
fields were observed (only existing in a one square cm area). We also
measured the voltages induced inside an 'instrumented-can' pacemaker
with two standard unipolar leads. Each iPod was placed in the air, 2.7
cm above the pacemaker case. The pacemaker case and leads were placed
in a saline filled torso simulator per pacemaker electromagnetic
compatibility standard ANSI/AAMI PC69:2000. Voltages inside the can
were measured.
Results
Emissions were strongest (˜ 0.2
µT pp) near a few localized points on the cases of the two iPods with
hard drives. Emissions consisted of 100 kHz sinusoidal signal with
lower frequency (20 msec wide) pulsed amplitude modulation. Voltages
induced in the iPods were below the noise level of our instruments (0.5
mV pp in the 0 – 1 kHz band or 2 mV pp in the 0 – 5 MHz bandwidth.
Conclusion
Our
measurements of the magnitude and the spatial distribution of low
frequency magnetic flux density emissions by 4 different models of iPod
portable music players. Levels of less than 0.2 µT exist very close (1
cm) from the case. The measured voltages induced inside an
'instrumented-can' pacemaker were below the noise level of our
instruments. Based on the observations of our in-vitro study we
conclude that no interference effects can occur in pacemakers exposed
to the iPod devices we tested.
Additional Information:
Low
Frequency Magnetic Emissions and Resulting Induced Voltages in a
Pacemaker by iPod Portable Music Players. Bassen, Howard. BioMedical
Engineering OnLine. February 2008, Volume 7.
http://www.biomedical-engineering-online.com/content/7/1/7
FDA's Office of In Vitro Diagnostics has approved the following new devices for marketing:
Dako
TOP2A FISH pharmDx Kit is a laboratory test used to help a doctor
assess the likely clinical course for certain patients with breast
cancer. The test uses fluorescent DNA probes to measure the number of
copies of the TOP2A (Topoisomerase 2 alpha) gene on chromosome 17 in
breast cancer cells. The TOP2A gene plays a role in cell division.
Changes in the number of copies of TOP2A gene indicate an elevated risk
of post-surgical recurrence of the breast cancer or decreased long term
survival. For more information visit,
http://www.fda.gov/cdrh/mda/docs/P050045.html
FreeStyle
Navigator Continuous Glucose Monitoring System is a glucose sensor that
reports glucose values continuously for up to 120 hours. These readings
are used with fingerstick results to detect trends and patterns in
glucose levels in adults, age 18 and over, with diabetes. For more
information visit, http://www.fda.gov/cdrh/mda/docs/P050020.html
_____________________________
To see additional In Vitro Diagnostic Devices recently cleared for marketing visit:
http://www.fda.gov/cdrh/oivd/
Click under the left hand column "Quick Links" on the link "New OIVD products"
_____________________________
FDA's
Office of In Vitro Diagnostics Device Recalls, a searchable database of
devices recently recalled by FDA's Office of In Vitro Diagnostics can
be found at:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/IVDRes.cfm
_____________________________
FDA's
Office of In Vitro Diagnostics Device Recalls, a searchable database of
devices recently recalled by FDA's Office of In Vitro Diagnostics can
be found at:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/IVDRes.cfm
Additional Information:
FDA's Office of In Vitro Diagnostics has approved the following new devices for marketing:
http://www.fda.gov/cdrh/mda/docs/P050045.html
FDA's Office of In Vitro Diagnostics has approved the following new devices for marketing:
http://www.fda.gov/cdrh/mda/docs/P050020.html
To see additional In Vitro Diagnostic Devices recently cleared for marketing visit:
http://www.fda.gov/cdrh/oivd/
Highlighted Reports
This section contains a sample of reports from all the MedSun
reports received during a particular period. The reports were submitted
by MedSun Representatives. In some instances the reports have been
summarized and/or edited for clarity. The entries that follow represent
a cross section of device-related events submitted by MedSun reporters
during the period February 1 through February 29. All other reports can
be searched under the ‘MedSun reports’ menu pane. Note: the two month
delay is due to quality control and follow-up.
CARDIOVASCULAR
Device: Monitor, Physiological
Model# DASH 4000
Manufacturer: GE Medical Systems Information Technologies
Problem:
GE DASH 4000 display spontaneously going blank or blacking out while in
use on NICU patients. The displays remain off despite multiple attempts
by clinicians / RNs to reboot the system. Clinicians / RNs unable to
view ECG tracings and other hemodynamics on NICU patients.
======================
Manufacturer response for Monitor, DASH 4000
======================
GE
has identified that the displays inverter is the cause of the problem.
GE has sent replacement inverters for all the DASH 4000s in the NICU.
We will be sending GE the problematic inverters for evaluation. GE
provided loaner DASH 4000s during this timeframe
(Note from FDA: A similar report has been submitted from the same facility describing issues with a new inverter).
Device: Pacemaker; Sensia
Manufacturer: Medtronic, Inc.
Device: Lead, Pacemaker, Atrial
Model# 4076
Other device# 45 cm
Manufacturer: Medtronic, Inc.
Device: Lead, Pacemaker, Ventricle
Model# 5076
Other device# 52 cm
Manufacturer: Medtronic, Inc.
Problem:
Patient had a permanent dual chamber pacemaker implanted by physician
with the manufacturer rep in attendance for a hypersensitive carotid.
At the end of the case and the following day there was a check of the
device which looks at its function. Follow up visits to the physician's
office in one month and then at 3 months demonstrated some 'high'
impedance issues. It was thought that it was perhaps a lead
dislodgement. Patient came in 3 months after the pacemaker implantation
for a 'lead revision.' When the manufacturer's rep checked the device
before the procedure, it was found that the A lead was in the V
insertion and the V lead was in the A position. The procedure involved
opening the pocket and switching the leads to the right orientation in
the generator. Patient was discharged 4 hours later. In follow up with
both the physician and the manufacturer the chart was reviewed and the
strips which are run during the pacer check (done immediately after the
procedure and a month later) showed the problem was evident. It had not
been communicated to the physician and physician does not routinely
look at the strips. Manufacturer has looked at their process, and is
adding some features to their paperwork including reading of the #'s on
the leads, which apparently the physician did not do at this time, and
assuring it is done or crossed through if the physician refuses to do
the check by reading the numbers. The physician could look over the
strips as well.
(Note from FDA: Good example of Human Factors issues seen with medical devices).
Device: Kit, Pressure Monitoring; Arterial Line Kit with Transducer; Medex LogiCal
Lot# 1147063
Other device# V-link V2847
Manufacturer: Smiths Medical
Problem:
During a dressing change, blood was observed backing up in arterial
line pressure tubing. The tubing was fractured at the manifold.
Approximately 20 ml of blood was lost. This is the sixth occurrence of
this nature in our facility.
RADIOLOGY
Device: Cardiovascular System, X-ray; Allura Xper FD10/10
Other Device# Control panel: Allura FD/10
Manufacturer: Philips Medical Systems
Problem:
This event occurred during patient transfer from the gurney to the
Philips Allura Xper FD10/10 biplane procedure surface, using a left
side approach. The left side must be utilized for patient transfers, as
additional equipment is adjacent to the right side of the table. The
detachable control panel (which looks like a keyboard), is responsible
for controlling the X-ray table, the C-arm, etc., and is usually
located on the left. However, in order to transfer this patient, the
control panel had been detached and moved to the end of the table. The
patient inadvertently hit the control panel with his foot and activated
the C-arm, which swung down and almost hit him in the head. The control
panel does not have a locking mechanism, or any way to prevent
accidental contact with the toggle switches. The risk manager and
biomedical engineers were easily able to replicate inadvertent action
of the device. Alternative control panel locations were discussed, but
it was concluded that no matter where it is located, the potential for
inadvertent activation is present. Therefore, the risk of harm to
patients and staff members remains a significant issue.
Currently,
the control panel is being removed from the rail, (which requires
removal of the lead protective radiation shield) and relocated to an
area away from action. However, it is still not completely "safe" from
unintentional activation, as it is possible for the buttons/switches to
still be "bumped". If Philips could make any of the following
modifications, i.e.: install a protective guard on the control panel,
devise a control panel lock-out switch, or incorporate a separate C-arm
"brake" button, events like this could be prevented. We notified the
vendor representative, but they did not get any indication that Philips
would be implementing any sort of locking option or other protective
mechanism.
(Note from FDA: Good example of Human Factors issues seen with medical devices).
Device: Computed Radiography System; Fuji Smart CR
Model# CR-1R346RU
Manufacturer: Fujifilm Medical Systems
Problem:
The CR reader located in the Inpatient Viewing area will periodically
not process the imaging for the CR plate that is being processed. When
this occurs, a clear image displays and a broken communication error
message appears with a reset button. Upon pressing the reset button,
which has to be pressed in order to proceed, an image displays.
However, the image that appears is not the correct image belonging to
the patient; it was the previously processed image from the previous
patient. This is an intermittent problem that may cause patients to
receive unnecessary treatment, or may cause treatment needed to be
missed. The CR reader was place out of service until further testing
resolves the above issues. I was actually able to talk to the Fuji rep.
There have not been any recent software upgrades or updates nor do they
have any upgrades that need to be installed. The rep and our Imaging
Services have identified the problem. There was a duplicate IP address
within the hospital and when there was a conflict, the connection would
drop off the network and momentarily lose connection and that is what
caused the CR to display an image from the previous patient. Imaging
services has received another IP address and the problem has been
resolved.
ANESTHESIOLOGY
Device: Anesthesia Machine; Aisys Carestation
Manufacturer: GE Medical Systems, LLC
Problem:
Biomed was paged regarding a leak on the anesthesia machine in the OR.
This machine was a brand new machine just put into service. Upon
arrival in room, noticed the desired tidal volume(TV) was not equal to
the Tvexp (there was a sizable leak of about 450mL). Biomed performed
the preliminary checks. The flow sensor module was swapped but there
was no effect. It was inspected but there was no sign of moisture or
physical damage. GE Clinical Application Specialist arrived to help.
Removed EZ change and condenser from system to see if this was cause of
leak, but no effect. Noticed bellows was driving all the way, with no
apparent leak. Application specialist asked user if they could switch
to PCV-VG and SIMV. The FiO2 (previously low 90s), increased to
mid-high 90s. But user still uneasy with anesthesia machine telling
them there was a leak. However since biomed was unable to troubleshoot
further while machine was being used on a patient, and patient vitals
were stable and SpO2 sat high, user agreed to continue the case. After
the case the machine was pulled out of service for further
investigation. The next day GE field service engineer troubleshot and
tested machine. Logs downloaded and sent to GE Engineering for
analysis. Nothing out of the ordinary was found in the logs. Field
service engineer found 2 faulty flow sensors reading erratically.
Replaced flow sensors. Machine tested according to manufacturer
======================
Manufacturer response for Anesthesia Machine, Aisys Carestation
======================
Sent
field service engineer to test and troubleshoot. Replaced faulty flow
sensors. Analyzed logs and reported nothing out of the ordinary.
Device: Tray, Spinal; Portex 25 Gauge Whitacre
Lot # 1242942
Catalog# 15545C-20
Other device# Bupivacaine HCl 0.75% in Dextrose inj 2ml
Manufacturer: Smith's Medical ASD, Inc.
Problem:
Anesthesiologist injected patient with Bupivacaine HCl 0.75% in
Dextrose 8.25%. Sensory effect was achieved, but not motor effect.
Anesthesiologist states that this is the third such case in the past
month or so.
Device: Flowmeter, Wall, O2; Western Medica Flow-Meters
Lot# FME0403
Catalog# FME107
Manufacturer: Western Medica
Problem:
Event describes noses separating from quick connectors while the quick
connect remained in the wall outlet. Quick connects on flowmeters are
defective, noses are falling out and flowmeters are falling off the
wall.
Analysis: Following a phone conversation with the user
facility, it was learned that one of the failed quick connectors was
from a flowmeter. The serial number was in the following format:
"FMxYYMM-", where "YY" represents the year and "MM" the month of
manufacture. Over a period of 6 years, Western manufactured Ohmeda
quick connectors with noses made of brass. Over that period, Western
has received reports of failures involving noses separating from the
body of the connector. Although the nose to body press fit connection
was deemed adequate for the expected application, the various forces
and pressures exerted on the connector under certain conditions could
weaken the connection over time, and result in separation of the nose
from the connector body. The number of pieces involved in nose
separation failures over that period represented 0.131% of product
produced. Quality Department Quantity: 15
Corrective Actions: A
formal engineering investigation was initiated to investigate this mode
of failure. Following engineering lab and production testing, it was
determined that changing the nose material from brass to stainless
steel significantly improves the retention of the nose in the connector
body. An engineering change was initiated and the nose material was
changed from brass to stainless steel. The change was implemented
approximately 3 years ago.
The unit being returned will be
evaluated and the old version quick connects were replaced with current
version quick connects at no charge. Western will continue to monitor
product return data for the purposes of trend identification, potential
improvements, corrective actions and/or countermeasures.
GASTROENTEROLOGY/UROLOGY
Device: Monitor, Esophageal PH; Bravo
Model# 7126
Lot# 0211286
Manufacturer: Medtronic Gastroenterology/Urology
Problem:
Bravo Capsule did not release from deployment device. The patient was
given instructions to remain on clear liquids for 36 hours and then
progress to a soft diet. This is due to a superficial esophageal tear
that occurred while trying to deploy the device. The patient was
released without complaints or problems.
======================
Manufacturer response for Monitor, Esophageal pH, Bravo
======================
Referred us to device Recall Letter dated December 2007.
Device: Dialysis Machine, CRRT; Diapact
Model# 2.10.1
Manufacturer: B. Braun Medical, Inc
Problem:
The Diapact CRRT did not alarm, but was pulling air through the PA
pressure sensor, which is located inside the machine, and air was
entering the blood tubing. There were no outside leaks or cracks. They
had to clamp the pressure line every minute or so to prevent the air
entering the blood stream. Pressure readings were negative and
believable.
======================
Manufacturer response for CRRT, Diapact
======================
It
was caused by a cracked PA connector that could not be seen by nursing.
Left connectors and trained inhouse staff about changing them
Device: Feeding tube; Transgastric Enteral Tube
Catalog# 20125
Manufacturer: Moss Tubes, Inc.
Problem:
Family reports observing RN's inject into balloon port. When tube was
inspected, it was found to have a burst balloon. This may have led to
tube malposition and associated problems. Tube (outside of body) looks
very similar to non-balloon feeding tube with side med/flush port.
Balloon port only labeled "H20 20cc". Several experienced nurses state
this could easily be understood as "flush with 20cc of water."
(Note from FDA: Good example of Human Factors issues seen with medical devices).
Device: Reprocessed Ethicon Trocar; Xcel Blunt Tip
Lot# 149680, 149764, and “unknown”
Catalog# H12LP
Manufacturer: Ascent Healthcare Solutions
Problem:
A total of 5 reprocessed trocars broke apart during use. One was from
lot number 149680, three were from lot number 149764, and one was from
an unknown lot number. The five broken trocars were sent to the
manufacturer (reprocessor) for analysis. The reprocessor's analysis
indicated that, based on their findings, a change would be made in the
disassembly procedure involved in reprocessing this trocar. According
to the reprocessor, "This modification will assist in mitigating future
occurrences of this nature."
PHYSICAL MEDICINE
Device: Air Transfer Mattress; HoverMatt
Model# HM34HS
Other device# Cannister - Model GSPJ115
Manufacturer: HoverTech International
Problem:
Bariatric patient with multiple trauma was being transferred from cart
to procedure table and back again multiple times one morning with use
of a hover mattress. Transfers were without incident until staff (5)
were transferring patient from the cart back to the patient's bariatric
bed. The hover mattress was inflated with the cart positioned next to
the patient's bed with cart brakes on. The bed had been lowered two
inches to enable sliding of the hover mattress with the patient on to
the bed. During the transport, the hover mattress tilted toward the
patient and the hover mattress and patient slid between the cart and
the bed. The patient landed on the floor. The patient was awake and
moved all extremities and shook head "no" to pain in neck/back.
Patient's trach and drains were secure. CT scans of head, neck, spine,
chest, abdomen, pelvis were ordered immediately with negative results.
Follow-up
reveals that the members of the lift team report that one of the issues
they have seen is that the hover mat will not uniformly inflate,
depending on the weight of the patient. Usually, the heavier the
patient, the more of a problem with uniform inflation. This may
indicate why the hover mat tilted in this particular case. They have
seen this before, but in other cases, this did not result in a patient
falling to the floor. They have not seen any other issues regarding
using a cart to bed transfer, or bed to cart, and it doesn't seem to
matter if the bed is bariatric or not.
GENERAL HOSPITAL
Device: Pump, IV; Symbiq
Manufacturer: Hospira Global Medical Affairs
Problem:
Levophed was being infused via a Symbiq pump to a patient. The patient
required Levophed at titrated dosages to keep his/her blood pressure
stable. The Symbiq pump failed and the malfunction code of S321 was
displayed. The patient's blood pressure dropped significantly and the
pump was pulled from service. A new pump was obtained and the Levophed
infusion was resumed. The patient's blood pressure was stabilized. The
cause of the failure was found to be a defective motor. The pump will
be sent for factory repair because motor replacement can not be done in
the field.
======================
Manufacturer response for Infusion Pump, Symbiq
======================
Malfunction log indicated code S321 and the unit's motor was replaced.
Device: Pump, IV, Module; Medley LVP
Other device# EEU0740
Manufacturer: Alaris Medical Systems, Inc.
Problem:
Initially Alaris pump screen showed Heparin infusion at 5 ml/hour with
appropriate drip chamber flow. Nurse noted drip chamber started to free
flow without pump beeping and screen still reading 5 ml/ hour. Patient
received approximately 5,000 unit bolus of heparin (50 ml). Infusion
stopped and pump removed from service. Patient without apparent injury.
Follow-up indicates that the pump had passed the occluder testing just
prior to the event, and subsequently failed the test when the pump was
tested after the event. The pump has since been sent back to the
company for corrective action.
The hospital has a total of 1,114
Alaris Large Volume Pump modules which are managed and serviced for the
hospital by a third party distributor. The pump distributor has
completed occluder testing of 1046 of the LVP modules, as of this date,
using the latest protocol provided by Alaris. Pumps which fail the
occluder testing are returned the the distributor's District Office
where the failure is verified, and failed pumps are then returned to
Alaris for X-ray inspection. Of the 1046 pumps which have been tested,
80 LVPs have failed the occluder test, or 7.65%.
Device: Tubing, IV
Model# FB1L03
Lot# 1247292
Manufacturer: Smiths Medical MD, Inc.
Problem:
Over the past month or two we have had two separate types of problems
with Medex IV tubing. I have already submitted a report on the first
problem (ball in drip chamber not sealing at the opening, so that air
enters the line) but it is still happening sporadically despite
changing lots. The second problem is leaking of the sets. This has also
occurred several times; once where the tubing connects to the drip
chamber and at least twice where the tubing connects to the pumping
mechanism. These incidents have all happened on different patients. The
manufacturer is aware of these problems. We do not have the tubing
available as they contained chemotherapy.
Device: Pump, IV; Alaris PC
Model# 8015
Manufacturer: ALARIS Medical Systems, Inc.
Problem:
The pump stopped infusing and read "System Error". The biomedical
assessment revealed that the pump's error log had one error code:
111.200.0. This is a known software problem which Alaris fixes by
re-flashing the pump's software. At this time, Alaris does not know the
cause of this particular problem. The pump will be sent to Alaris for
evaluation and repair. There was no patient harm as a result of this
failure.
Device: Catheter, PICC; V-Cath
Lot# 4Fr 1026, 1029, 1030; 5Fr 1033
Catalog# 4Fr: 4029-1660; 5Fr: 5029-2660
Manufacturer: HDC Corp.
Device: Dilator; Coaxial Dilator Micro-Introducer
Manufacturer: Enpath Medical, Inc.
Problem:
There have been multiple problems with the introducer kits that require
the Seldinger technique. They fall into three groups:
1) Leading edge of Peel-away introducer is flared which would likely cause injury if pushed into a vein (have seen twice).
No response yet
2)
Tip of dilator won't allow guidewire to pass. (This has happened around
four times to several IV nurses, but visual inspection of kits reveals
a non-circular opening in about 15% of dilators.) This results in a
complete redo of insertion which can be difficult on some patients.
Problematic
dilators come from a company called Enpath. HDC has sent dilators from
a different company. They function the same way. Reportedly, HDC
doesn't manufacture the dilators. They buy them from third parties:
Enpath and others. The Enpath dilators were the ones that were having
the problems. Another company's were offered as replacements so that
the existing kits could still be used. They come in individual sterile
packs.
3) Handle on end of guidewire came off so that wire could
not be removed properly (occurred once). This required a second
insertion through the existing introducer.).
Device: Pump, Implantable, Pain Relief; On-Q PainBuster
Other device Ref #PM023-A
Manufacturer: I-Flow Corporation
Problem:
A patient with Hirschsprung's disease, who a year and a half ago,
underwent an abdominal perineal resection. He had a non-healing wound
for about a year until he underwent closure of two perineal fistulas.
During the procedure, while under fluoroscopy, a radiopaque linear
density was noted. The area was probed, and a retained foreign object
was removed, which turned out to be a piece of the split introducer
from the I-Flow ON-Q Painbuster.
According to the manufacturer's
representative; this issue has been sent onto the corporate office and
a reply has been requested with any information on advancements in
product manufacturing that will help prevent this from occuring.
Possibility
of including markings or color coding on the sheaths (similar to that
on the catheters), leads to the question of what to do if the sheath
does peel unevenly and how to remove the sheath at that point?
A
suggestion for prevention of this occurance is to slide the sheath back
out over the catheter until it is entirely removed from the pt and then
peel the sheath apart. Similar to what they currently do, they may need
to steady the catheter as they pull pack on the sheath to prevent the
catheter from sliding back out.
Device: Tubing, IV, PCA; Gemstar
Lot# 61-180-5H
Catalog# 19559-01
Manufacturer: Hospira Global Medical Affairs
Problem:
The patient awoke at home in the morning, and noticed the pump tubing
was wet near the filter. She called the clinic and was instructed to
stop the pump, wash her skin in case she came into contact with the
chemotherapy, and to return to the clinic.
This is the fourth
report we have submitted regarding problems with this tubing leaking.
The first three reports were submitted one month ago. The lot # for the
previous reports was 571635H. The lot # for this report is 611805H.
According to clinic staff, additional incidents have occurred since,
but I do not have that information at this time. It seems the issues
involve leaking around the filter.
Device: Hypothermic Device, Head; Olympic Cool-Cap
Manufacturer: Olympic Medical Corporation, a Natus Company
Problem:
Term female baby admitted to NICU on 02/15/08 for perinatal asphyxia.
Baby met criteria and placed on Olympic head cooling system.
Approximately thirty minutes after cooling was initiated, the
specialist reported that the cap temperature was not responding to
settings and the cap temperature continued to fall despite increases
the cap temperature. Cap reading was consistently between 5.2 and 5.5
(manufacturer recommends cap no lower than 8 degrees). A warmer was
used to maintain appropriate rectal and fontanel temperatures. Also,
orders were placed to check the baby’s scalp every four hours
(manufacturer recommends every 12 hours) and the baby was repositioned
every two hours. A telephone call was placed to Olympic technical
support line. After several hours it was determined that there was a
power supply issue that prohibited the machine from responding to the
message from the software to increase cap temperature. Possible risks
for continuing to use the cap were discussed with technical support;
however given the baby’s condition a medical decision, with consent
from the family, was made to continue with the therapy. No other
complications were noted during the duration of the treatment.
Device: Catheter, PICC; VAXCEL-PASV PICC/5/2
Model# MOO1454700
Lot# 1224626 and 1232872
Manufacturer: Boston Scientific Corp.
Problem:
Seven PICC lines have been identified as apparently defective as
patients have returned due to leaking. Found all have a crack in leg of
catheter. Removed and replaced with new line.
LABORATORY/DIAGNOSTIC TESTS
Device: Needle, Safety; Vacutainer Eclipse Blood Collection Needle
Lot# 7290975
Catalog# 368607
Manufacturer: Becton Dickinson
Problem:
The safety device on the BD Vacutainer Eclipse Blood Collection needle
did not work properly. The safety device popped off and the employee
was stuck while trying to activate the device. This is the third
incident involving this type of device, and there have been many "near
misses". The cover of the device flips up, but does not completely
cover the needle, or else it slips to the left or right of the needle.
Additionally, the caps have been known to break off. The manufacturer's
response when they were notified of this failure was: There are a
number of reasons which could affect the shield popping-off on the BD
Eclipse Blood Collection Needle. In many instances, there is a
combination of factors at work, i.e. manufacturing issues, storage
issues, and handling issues. It is difficult to rule out any of these
when dealing with the shield on the Eclipse needles.
Device: Kit, Urine Pregnancy Test; Fisher Sure-Vue Serum/Urine HCG-Stat
Lot# 7090052
Manufacturer: Innovacon, Inc.
Device: Kit, Urine Pregnancy Test; Fisher Sure-Vue Serum/Urine HCG-Stat
Model# 7070191
Catalog# 23900530
Manufacturer: Innovacon, Inc.
Problem:
False positive result obtained by health assistant performing
qualitative urine hCG pregnancy test on patient using Fisher Sure-Vue
Serum/Urine HCG-Stat kit lot hCG7090052. The test was repeated using
same kit lot and the same positive result was obtained. A positive
result was also obtained using kit lot hCG7070191. However, a negative
result was obtained on the same specimen using kit lot hCG7070060.
Patient was a postpartum patient who denied having intercourse since
delivery approximately one month prior to event so it was expected that
result would be negative. A blood specimen was drawn on the patient for
a quantitative hCG test performed in the central laboratory which came
back negative (<5 mIU/mL).
OPTHALAMIC
Device: Pack, Vitrectomy, Light Probe; Total Plus Pak with a 2500 Probe
Lot# 7028447X
Manufacturer: Alcon Laboratories, Inc.
Problem:
Report from unit states: The fiberoptic light probe that comes in our
20 ga Total Plus Vitrectomy Pak began to char at the tip of the probe
during the procedure. The surgeon withdrew the probe from the patient's
eye. The probe was removed from the field and the packaging was
collected for identification. The company, Alcon, was contacted and all
packs with that lot number were sequestered awaiting word from the
vendor. Doctor states that there was a burn on the tenons of the
patient, which he states was not of great severity, but was evident to
the eye.
Device: Phaco Emulsifier; Sovereign Compact Console Universal; White Star
Manufacturer: Advanced Medical Optics, Inc.
Problem:
The unit with handpiece was primed and tuned before the procedure
started. Everything checked out. During the procedure the unit had low
power then stopped working. Staff did not want to proceed further. The
patient sustained vitreous loss with lens drop. Doctor received a
consult to send the patient to a specialist for the corrective
procedure, which involved removal of lens material via a pars plana
approach.
Summary of MedSun Reports Describing Adverse Events With Transcatheter Septal Occluders
The
purpose of providing this summary, and the following reports, is to
inform you about problems reported to FDA by the MedSun clinical
community. These, as well as non-MedSun reported problems involving
this device may also be investigated by searching FDA’s on-line MAUDE
database
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.cfm.
Transcatheter
septal occluders are devices delivered through a catheter and placed to
close defects (holes) in the septum (walls) between the two atria or
the two ventricles of the heart.
Over the past 2 years, MedSun has
received 10 medical device adverse event reports involving
transcatheter septal occluders associated with three manufacturers: AGA
Medical (8), NMT Medical (1) and W.L. Gore and Associates, Inc. (1).
The reports were submitted by 6 hospitals between April 1, 2006 and
April 17, 2008. The most frequently reported device problems are
(please note, several problems are often reported in one report):
•Problems preventing implant of the device requiring removal (7)
•Migration of the device (4)
•Difficulty removing the device (2)
There
are no MedSun reports involving a patient death during this time
period. The most frequently reported patient problems are (again, more
than one problem is often reported per report):
•Need for an additional surgical procedure or prolonged surgery (7)
•Need for removal of foreign body (3)
•Required hospitalization related to the event (3)
Of
the reports that list patient age, 1 report has a patient age listed as
less than 21 years and no reports have a patient age listed as greater
than 21 years. All 10 reports listed patient gender; 5 reports involve
female patients and 5 reports involve male patients.
These
MedSun reports contribute to FDA’s post-market experience and
understanding of problems associated with the use of these devices.
MedSun Transcatheter Septal Occluder Adverse Event Reports received between April 1, 2006 and April 17, 2008
|
Device |
Device Identifiers |
Event Description |
|
AGA MEDICAL CORPORATION/Amplatzer |
Catalog: 9-ASD-019 Lot: M05G25-2B/TD> |
Upon
release of the Amplatzer device across the atrial septum it became
mis-aligned and became "free floating" in the left atrium. Device was
captured with a snare but unable to retrieve. Device secured in
position. Patient
to OR for retrieval and repair. |
|
AGA MEDICAL CORPORATION/AMPLATZER |
Lot: M03C20-25 |
Patient with Large Secundum ASD (Atrial Septal Defect) had insertion of
Amplatzer occluder device over a year ago. Within the past year, he has
recently been hospitalized twice. Late last year, presented with
blurred vision of left eye associated with headaches which occurred in
A.M. extensive Neurology, Cardiology and Opthomology work up
demonstrated left temporal field defect with abnormal fundoscopic exam
and evidence of small microemboli effecting small area of optic nerve.
Hyper coag work-up was negative. He then presented one month later with
left arm and leg paresis. He had magnetic resonance venogram (MRV),
magnetic resonance angiogram (MRA) and transesophageal echocardiogram
(TEE). TEE demonstrated a small residual ASD in the superior part of
the device of the superior vena cava (SVC) end. No clots or vegetation.
Neurology symptoms were thought to be transient ischemic attacks
(TIAS). Based on findings, all MDs involved in care determined that
best course of action would be to remove device and repair ASD
surgically, especially with recurrent TIAS in the absence of any other
cause. Device was sent to pathology and not as much scar tissue was
noted on the side that would have been nearest to the left side of the
heart. Since removal, TIAS have stopped, blurred vision of left eye
diminished. |
|
NMT MEDICAL, INC./PFO CARDIOSEAL |
Model: 33MM |
The
patient had a Cardioseal device placed approximately one month prior
for Patent Foramen Ovale (PFO). The patient had a history of prior
stroke and presented with current visual disturbances and a
near-syncopal episode. Transesophageal echocardiogram (TEE) revealed
adequate closure of the Atrial Septal Defect (ASD). However, there were
areas of thrombus adjacent to the closure device on the left atrial
side. As a result, the closure device was removed and primary repair of
the ASD was performed. |
|
AGA MEDICAL CORPORATION/AMPLATZER |
Lot: M06K16-18 |
Patient
arrived on the unit, status post device closure of ASD (atrial septal
defect). The patient was responsive on arrival with stable vital signs
and was interactive. Within one hour of arrival on the unit, patient
had sinus tachycardia after vomiting and returned to baseline. Ten
minutes after emesis, patient complained again of persistent nausea,
vomiting with red tinge in emesis and complaint of feeling unwell.
Sinus tachycardia occurred while vomiting. Fellow was notified - 2 RNs
were present at the bedside. Patient became unresponsive, eyes rolled
back, frothing at the mouth. Code light was activated. Patient became
bradycardic to 30, MD and RN staff responded to the event. Patient was
tonic, pulseless, and apneic. CPR was initiated. Cardiac code was
called with fast response by cardiac code team. 2 rounds 1ml 1:100,000
Epinephrine were administered resulting in return of heart rate to 70,
sinus rhythm with perfusion, chest compression held with bag-mask
ventilation. Oral airway was inserted. Transferred to other unit within
6 minutes of event onset. |
|
AGA MEDICAL CORPORATION/AMPLATZER |
|
A
24MM Amplatzer device was placed in secundum for an (ASD) atrial septal
defect. Position confirmed by TEE(transesophageal echocardiogram) and
fluoroscopy. Immediately upon release of the device, it embolized into
the left atrium (LA), and subsequently into the left ventricle (LV).
Multiple attempts to retrieve the device were unsuccessful.Patient was
taken to the OR for operative removal of the device and closure of the ASD. |
|
AGA MEDICAL CORPORATION/AMPLATZER |
Model: 10 FR 45 DEGREE X 80 CM Lot: M06J19-58
|
Patient
undergoing atrial-septal defect repair. A 6 french standard sheath was
placed in the right femoral vein. Then the intracardiac
echocardiography (ice) catheter was advanced to the right atrium and
under guidance from ice, a multipurpose catheter was utilized to go
across the asd over a rozen wire. After this the balloon sizing
Amplatzer balloon was utilized. This showed the ASD to be roughly 27
mm. after this, the Amplatzer device was advanced and during deployment
there was embolization into the pulmonary artery. After this, multiple
attempts were made at device extraction using multiple catheters. The
jr-4 guide, the multipurpose guide, a left internal mammary artery
guide, were the catheters that were utilized. Using multiple steering
devices such as the 6 French and snare 7 French, an RV biopsy forceps
and vascular retrieval forceps and other devices from endoscopy the
device was pulled back into the common illiac. After this, the 9 French
sheath was exchanged for a 14 French sheath and further attempts made,
however, the device could not be retrieved and
vascular surgery was contacted for surgical removal of the device from the right common iliac vein. |
|
AGA MEDICAL CORPORATION/AMPLATZER |
Model: 9-ASD-010 Lot: M07D24-44 |
A
10-MM Amplatzer septal occluder was selected; however, the device was
malformed on delivery and removed without consequences. Attempts at
reconfiguring the device were unsuccessful, and it was felt to be
related to a manufacturer's abnormality. |
|
AGA MEDICAL CORPORATION/AMPLATZER |
Model: 9-ASD-016 Lot: MO7J26-19 |
Difficulty
loading a16 mm device into an 8 fr. delivery sheath. We changed to a 9
fr. delivery system. The device loaded appropriately, appeared normal
going through the sheath but had a cobra like appearance when released
into the atrium. The device retracted into the sheath and was removed
from the patient without harm. The device was given to the manufacturer. |
|
AGA MEDICAL CORPORATION/AMPLATZER |
Lot: MO7K23-08 |
ASD
closure device appeared to be seated well on the rims with ice and was
deployed. The device migrated to the left ventricle, then to the aortic
arch. The device was retrieved to the level of the iliacs in the aorta.
Patient was then taken to the operating room for extraction of the
device by vascular surgery. Patient tolerated the procedure without
complications. Patient will need to be rescheduled for closure of ASD.
|
|
W.L. GORE AND ASSOCIATES, INC./ HELEX |
Catalog: HX1525 |
The
patient underwent an implantation of a gore helex septal occluder
device to close a patent foramen ovale. Several days later, the patient
developed an exertional dyspnea after lifting her child from a
stroller. Evaluation in the cardiac services clinic and in radiology
revealed embolization of the device from the atrial septum to the
abdominal aorta. The patient had the device successfully removed from
the aorta seven days after the implant. |
Summary of MedSun Reports Describing Adverse Events Involving Burns or Fires during Surgery in the Head and Neck Area
The
purpose of providing this summary, and the following reports, is to
inform you about problems reported to FDA by the MedSun clinical
community. These, as well as non-MedSun reported problems involving
this device may also be investigated by searching FDA’s on-line MAUDE
database
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.cfm.
Over
the past 2 years, MedSun has received 8 adverse event reports involving
fires or burns associated with the use of ESU, laser or cautery devices
during surgery in the head or neck area. The proximity of the
procedures to an oxygen enriched atmosphere is often a contributing
factor to these occurrences. The reports were submitted by 8 different
hospitals between December, 2006 and January, 2008. The surgical
procedures represented in these reports were:
• 4 tonsillectomy and/or adenoidectomy procedures
• 2 tracheotomy procedures
• 1 laser procedure in the patient’s lung
• 1 surgery to remove lipoma on the neck
No
reports involved a patient death. The patient injuries listed below
were reported in 4 of these 8 reports. In the other reports, prompt
intervention by the clinicians appears to have prevented a patient
injury.
• 1st and 2nd degree burn – procedure aborted
• Minor burn in mouth - tonsillectomy
• Patient, bronchoscope, laser fiber and trach tube showed evidence of a burn.
• Patient’s chest hair was singed – no apparent burn
• 2nd degree burn to trachea and bronchi
Of
the reports that listed patient age, 4 had a patient age listed as less
than 21 years and 3 had a patient age listed as greater than 21 years.
Of the reports that listed patient gender, a total of 4 reports
involved female patients and a total of 3 reports involved male
patients.
These MedSun reports contribute to FDA’s post-market
experience and understanding of problems associated with the use of
these devices.
BURNS OR FIRE DURING ESU / LASER PROCEDURES OF THE HEAD OR NECK
|
Device |
Device Identifiers |
Event Description |
|
Electrosurgical Pencil (Covidien Valleylab) |
E2450HN5B (part of kit) |
While undergoing excision of lipoma of neck, the surgeon used an
electrosurgical pencil to cauterize a bleeder. The pencil was noted to
be arcing. Immediately thereafter, fire was observed under the drape. |
|
Electrosurgical Pencil (Covidien Valleylab), Electrode, ESU, bipolar
forceps (Covidien Valleylab), Electrode, ESU, bipolar forceps
(Aesculap), Generator, ESU, Argon beam (Conmed Electrosurgery) |
various |
This incident was reported to me from nurse manager, circulator, and
scrub person. Patient status post tonsillectomy bleed. The surgeon was
using both a bipolar and a monopolar cautery on the case. The Valleylab
bipolar forceps were used as a retractor to expose behind the base of
the tongue. It was not attached to the cautery machine. The Aesculap
bipolar forceps and the Valleylab suction coagulator E2505-10F were
used to resect the uvula and cauterize the tonsillar fossa. The surgeon
stated the only explanation he could give for the source of the burn
was current flow to the retraction forceps. He stated that the area
that was cauterized was always in his direct view, and no arcing or
sparking was noted. |
|
Laser System (Laserscope) |
Model 813 KTP 100W YAG, DP with 630 dye Module |
Doctor
was performing laser surgery in patient lungs in an oxygen enriched
environment, which resulted in burns to the patient as well as the
bronchoscope, laser fiber, and tracheal tube. |
|
Electrosurgical Pencil (ConMed Electrosurgery) |
Conmed Hand Control with UltraClean, Catalog 131309 |
When using cautery in the mouth during a tonsillectomy and
adenoidectomy (T&A) procedure, the doctor reported a flash (fire).
The bovie tip and the tonsil sponge were immediately removed from the
mouth. The sponge showed some evidence of a burn. Evaluation revealed
the mouth and airway did not seemingly suffer any burns as a result of
this incident. |
|
Ablation wand, ENT (Arthrocare Corporation) |
ArthroCare ENT Coblator |
During
tonsil/adenoid surgery, coblator stopped working properly; smoke coming
from tip of probe. MD unable to clear tissue. Used second device, and
it worked properly. |
|
Generator, ESU (Covidien Valleylab) |
Model Unknown |
During a tracheotomy the patient's O2 saturation began to drop. This
required an increase in oxygen to 100%. This caused spillage of oxygen
out of the mouth into the area of the wound. There was a short flash of
fire on the chest secondary to electrocautery. The fire was put out
with sterile water. The patient's chest hair was singed. No apparent
burn. |
|
Electrode, ESU, suction coagulator (Covidien Valleylab) |
Model: E2505-10FR |
While
the surgeon was cauterizing the adenoids, the oral cavity caught fire.
Saline solution was poured into the mouth. There was no injury to the
patient. |
|
Generator, ESU (Covidien Valleylab) |
Brand: Force FX |
A spark was noted at the time of the tracheotomy at the insertion site,
while a bleeder was being cauterized. Oxygenation was stopped
immediately, the endotracheal tube removed, and a tracheal tube
inserted. The trachea was flushed with normal saline, cleaned and
suctioned. A fiber-optic evaluation of the trachea and bronchi was
done, which revealed a possible second degree burn. |
Updated May 1, 2008