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U.S. Department of Health and Human Services

MedSun: Newsletter #21, February 2008

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Newsletter #21, February 2008

Articles

FDA Public Health Notification: Patient Burns from Electric Dental Handpieces

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This is to inform you about serious patient injuries, including third degree burns, associated with the use of poorly maintained electric dental handpieces, and to recommend specific actions to prevent or minimize the problem. While this notification is directed to dental health professionals, the following information may be useful to all users of electric handpieces.

Additional Information:

FDA Public Health Notification: Patient Burns from Electric Dental Handpieces
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm062018.htm

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FDA Public Health Notification: Deaths reported following Radio Frequency Ablation of Lung Tumors

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This is to alert you to reports of deaths associated with the use of radio frequency (RF) ablation devices during lung tumor ablation.

Additional Information:

FDA Public Health Notification: Deaths reported following Radio Frequency Ablation of Lung Tumors
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm063021.htm

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FDA Public Health Notification: Unretrieved Device Fragments

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This is to advise you of serious adverse events associated with unretrieved device fragments (UDFs) and provide recommendations to mitigate these events. A UDF is a fragment of a medical device that has separated unintentionally and remains in the patient after a procedure. Patients may not be aware that this has occurred. The Center for Devices and Radiological Health (CDRH) receives nearly 1000 adverse event reports each year related to UDFs. These have included more than 200 different medical devices and numerous medical specialties.

Additional Information:

FDA Public Health Notification: Unretrieved Device Fragments
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm062015.htm

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Waking up to Hospital Bed Entrapment Risks

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Patient entrapment occurs when a patient gets caught or entangled in the openings or gaps around the hospital bed; it usually involves a side rail. Deaths and injuries from entrapment result when the patient slips between the mattress and side rail or gets entrapped within the side rail itself. Entrapment of a patient’s head, neck, or chest is life-threatening.

Additional Information:

Waking up to Hospital Bed Entrapment Risks
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/TipsandArticlesonDeviceSafety/ucm064614.htm

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Reporting Tip

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"Is This Reportable?"

Sometimes the FDA receives the following question concerning medical device adverse event reporting, "Is this reportable?" Strictly speaking, what is "reportable" under the SMDA (Safe Medical Device Act) is well defined - adverse events involving medical devices that have, or may have, contributed to a death or serious injury.

But we also want to encourage you to report "voluntary" adverse events that do not meet the requirements for mandatory reporting.

These are the types of events where a possibly harmful situation is narrowly avoided or has potential for an adverse outcome. Even if a product isn't used because a defect or malfunction is noted on initial inspection, or prior to use, but could be a safety hazard, we'd like to hear about it. Additionally, you should not hesitate to report an event that you believe to be common, since your report may be the one that provides the additional information needed for FDA or device manufacturers to "connect the dots," resulting in action being taken to address the reported problem.

For specific questions about whether or not an event is reportable, CDRH's Reporting Systems Monitoring Branch can be contacted. Voluntary reports can be submitted directly to the FDA's MedWatch Adverse Event Reporting program online, by phone (1-800-FDA-1088), or by returning the postage-paid FDA form 3500 (which may be downloaded from www.fda.gov/MedWatch/getforms.htm) by mail to: MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787 or by fax to: 1-800-FDA-0178.

Additional Information:

Information about user facility medical device reporting requirements, go to
http://www.fda.gov/cdrh/mdr/
http://www.fda.gov/medwatch/report/hcp.htm

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HeartNet

Of Special Interest to Electrophysiology and Cath Lab Staff/HeartNet

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Compatibility of Pacemakers and Implantable Cardiac Defibrillators Exposed to RFID Readers
Inderscience Publishers
By: Seth Seidman et al, Food and Drug Administration

Results of this test included potentially harmful inappropriate tachyarrhythmia detection and delivery of therapy or complete inhibition of cardiac pacing by the exposed ICDs and pacemakers.

To access the full text of the article, a subscription and payment is required.

Additional Information:

To view the article abstract, visit
http://www.inderscience.com/link.php?id=15848

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KidNet

Of Special Interest to Pediatric and Neonatal Staff/KidNet

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Adverse Events in the Neonatal Intensive Care Unit: Development, Testing, and Findings of an NICU-Focused Trigger Tool to Identify Harm in North American NICUs
Pediatrics (Journal of the American Academy of Pediatrics)
By: Paul J. Sharek; et al

A newly developed NICU-focused trigger tool appears successful at identifying adverse events.

Additional Information:

To view the article’s full text, visit:
http://pediatrics.aappublications.org/cgi/content/abstract/118/4/1332

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LabNet

Of Special Interest to Laboratorians/LabNet

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Reporting Problems with Glucose Meters and Continuous Glucose Monitoring Systems

Please visit http://www.fda.gov/cdrh/oivd/reportingglucose.html for information to provide you with a least burdensome way of reporting the problems you may encounter when using your Glucose Meter or Continuous Glucose Monitoring System (CGMS).
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Glucose Meter Test Results: Useful Tips to Increase Accuracy and Reduce Errors

Have you ever wondered why you got a bad glucose meter test result when there is nothing obvious wrong with your meter, your test strips are new, and you’ve been running glucose tests for years? The simple answer is that glucose meters are not perfect, and neither are the people who use them!

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Draft Guidance for Industry and FDA Staff - Total Product Life Cycle for Portable Invasive Blood Glucose Monitoring Systems
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LabNet Focus Call on User Experience with Glucose Meters in Healthcare Settings
By: Mingdong Zhang, M.D., M.P.H., Ph.D., OSB and OIVD, CDRH, FDA

With approximately 20 million individuals diagnosed with diabetes in the U.S. and the number increasing rapidly, FDA is very interested in learning more about user experience with glucose meters. Diabetes care has become a significant public health burden. Accurate measurement of blood glucose with glucose meters is important in the management of diabetes to reduce complications. Erroneous readings of blood glucose levels could lead to serious clinical consequences. Each year, CDRH/FDA receives more than 10,000 medical device reports (MDRs) on blood glucose meters. These reports capture serious adverse events including malfunction, injury and death. The majority of the reports cite inaccurate readings as the problem. FDA is currently working to determine major causes for and identify solutions for inaccurate readings of glucose meters. Given the significance of diabetes care in the U.S., any improvement in the accuracy of glucose monitoring would have a great public health impact.

On October 9, 2007, CDRH conducted a focus call on user experience with glucose meters in health care settings with nine LabNet hospitals.

The purpose of the discussion was for the FDA to gain better understanding of user experience with glucose meters in point-of-care settings. The discussion focused on usage of the meters on clinical units, important criteria for selecting meters, common problems with glucose meters, medical problems that might be caused by glucose meters, and training of personnel using glucose meters.

The following points were made by the LabNet facility participants during the focus call:
•Glucose meters are used in both outpatient and inpatient units. Most facilities use one type of meter on all clinical units.
•Accuracy and precision are the most important criteria in glucose meter purchasing decisions.
•Some of the common problems with glucose meters are use errors and measurement inaccuracies. Concerns were expressed about different readings by different meters on the same sample (the difference can be as high as 100 points).
•Of particular interest to FDA was the discussion about the kind of patient conditions that might significantly affect glucose meter readings. Many facilities reported instances in the hospital where inaccurately high blood glucose meter readings were obtained on patients who were very ill. These patients were given insulin and subsequently became hypoglycemic. The conditions of concern included: very high or very low hematocrit, excess uric acid levels, certain medications, vasopressors, septicemia, physiological conditions such as heart failure, an ejection fraction less than 20%, pitting edema, severe dehydration, hypotension, and peripheral vascular disease.
•Tests are usually repeated or laboratory confirmations are requested when results are in doubt. Some facilities implemented internal guidelines for repeating tests, e.g., a test is repeated when a critically high (over 400mg/dL inpatient or over 300 mg/dL outpatient) or a critically low (below 50 mg/dL) test result is obtained.
•Quality controls are usually run every 24 hours (on two levels of quality control), and all facilities have internal training schedules/procedures for personnel using glucose meters.

FDA very much appreciates the participation of LabNet facilities in the discussion of user experiences with glucose meters in health care settings. The feedback is very valuable. The information from this discussion will help greatly in the development of strategies to address common problems with glucose meters and to improve the safety of this device.
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Analysis of Glucose Meter Medical Device Reporting (MDR)/MAUDE database

From August 2006 to January 2007 (6-month period):
Total number of MDR reports: 4,629
Event type:
• Malfunction: 3,276 (70.8%)
• Injury: 1,259 (27.2%)
• Death: 11 (0.2%)
• Invalid data: 25 (0.5%)
• Other: 58 (1.3%)

Analysis of reported events by device problem code indicated that most MDR reports were related to “erroneous reading” or “inaccurate test results”.



Reported Events by Device Problem
(August 2006-January 2007)
Problem Percentage of Reports Received (% of n=4,629)
Test results, inaccurate 47.66
Test results, high 16.33
NOT APPLICABLE14.47
Control settings incorrect 12.49
Error message given 8.81
Device, incorrect care/use of7.86
Other(for use when an appropriate device code cannot be identified7.50
Results incorrect4.90
Measurements, inaccurate4.80
Procedure, improper/incorrect4.13
Test results, low 3.24
Power-up, failure to 3.00
Readings, high 2.87
Expiration date exceeded 1.97
Device failure 1.94
Display, failure to 1.86
Malfunction 1.71
Self-activation/keying 1.62
False readings 1.06
Readings, unable to obtain 0.99
Display, incorrect 0.91
Measurements, incorrect 0.89
Components, missing 0.73
Computer software error 0.69
Melts 0.67
Readings, low0.67
Unknown (for use when the device problem is not known)0.65
Locking mechanism failure 0.52
Blank screen0.32
Packaging, unsealed0.32
Display, erratic0.30
Nonstandard0.24
Leak(s)0.22
Therapeutic results, unexpected0.19
Device, defective 0.19
Lockout mechanism failure0.13
Continuous mode failure 0.04
Product, incorrect 0.04
Programming calculations, incorrect0.04
Packaging, incomplete/missing0.04
Separate, failure to 0.04
Contamination 0.02
Imprecision 0.02
Deliver, failure to 0.02

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FDA Clears First Test Designed to Detect and Identify 12 Respiratory Viruses from Single Sample
The U.S. Food and Drug Administration today cleared for marketing a test that simultaneously detects and identifies 12 specific respiratory viruses.

For full article text, visit: http://www.fda.gov/bbs/topics/NEWS/2008/NEW01770.html
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FDA Clears First Quick Test For Drug-Resistant Staph Infections Test Identifies MRSA Bacterium in Two Hours

The U.S. Food and Drug Administration (FDA) today announced it has cleared for marketing the first rapid blood test for the drug-resistant staph bacterium known as MRSA (methicillin-resistant Staphylococcus aureus), which can cause potentially deadly infections.
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Group Issues Consensus Statement on HbA1C Standardization
Clinical Laboratory News
By: Deborah Levenson

The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) and three diabetes groups have released a consensus statement calling for worldwide standardization of hemoglobin (HbA1c) test results through adoption of the IFCC reference method.

Additional Information:

Reporting Problems with Glucose Meters and Continuous Glucose Monitoring Systems
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/GlucoseTestingDevices/ucm162002.htm

Visit the following webpage for helpful tips
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/GlucoseTestingDevices/default.htm

Draft Guidance for Industry and FDA Staff - Total Product Life Cycle for Portable Invasive Blood Glucose Monitoring Systems
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm079138.htm

FDA Clears First Test Designed to Detect and Identify 12 Respiratory Viruses from Single Sample
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2008/ucm116829.htm

FDA Clears First Quick Test For Drug-Resistant Staph Infections Test Identifies MRSA Bacterium in Two Hours
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm161552.htm

Group Issues Consensus Statement on HbA1C Standardization
http://www.aacc.org/publications/cln/2007/nov/Pages/inside1_1107.aspx

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Highlighted MedSun Reports

Highlighted Reports

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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 November 1 through November 30. 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.


ANESTHESIOLOGY

Device: Endotracheal Tube; Mallinckrodt; Catalog# 86642
Manufacturer: Nellcor (A Division of Tyco Healthcare Group)
Problem: The patient who was going to the OR for a PDA (patent ductus arteriosus) ligation had a peripheral IV in her foot and a PICC line in her scalp. The anesthesiologist switched out the baby’s ETT (endotracheal tube) for an ETT with a side-port, luer-lock attachment for CO2 monitoring. At some point during the case, the peripheral IV became infiltrated and difficult to flush. The baby required a transfusion, and the anesthesiologist intended to access the PICC line, but instead infused the blood into the ETT side port. The procedure was stopped and the lungs were lavaged. Only a small amount of blood entered the lungs.


CARDIOVASCULAR

Device: Transmitter, Telemetry, Viridia Model# M2601A; Monitor, Central; Alarm Paging System
Manufacturer: Philips Medical Systems; Emergin, Inc.
Problem: A patient was connected to a Philips telemetry transmitter that was being monitored by a Philips CIC (central information center) monitor. The alarms from the CIC monitor were being sent to an Emergin remote notification paging system. According to the Emergin paging logs, two separate “Leads Off” alarms were generated at about the same time. Sixty seconds later, the central monitor alarmed “Can not analyze ECG” and “Transmitter Off.” The patient was found unresponsive approximately six and a half hours later; a code was called and the patient was pronounced dead. A further analysis of the telemetry system found that the telemetry transmitters are configured to turn off ten minutes after not having a valid ECG waveform to transmit. This is an option that can be turned off so that the transmitters stay on at all times. Our hospital has elected to turn off the automatic shut off feature on all Philips telemetry transmitters.

Device: Pad, Electrodes, ECG, ECG Backpad; Lot# 0710021; Catalog# 01-3130
Manufacturer: CONMED Corporation
Problem: The patient came in for a kidney stone removal. After the surgery, while in the recovery room, the patient was noted to have multiple pin size bleeding spots where the ECG adhesive monitoring pad had been on his back. The physician was notified, but no new orders were specified and no additional medical intervention was required. The patient had only seasonal allergies, no allergies to latex or adhesive, and their skin is in good condition otherwise. Additionally, the patient had no history of liver or renal failure and had good nutritional status. The pad was removed in OR at the end of the case just before the patient was sent to the PACU. It remains unknown why this patient had this outcome, or what may have contributed to this event. Staff reports that they have had other patients complain of a rash or redness in the same area that the ECG pad was placed, but no others have seen the pinpoint bleeding like this particular patient experienced. Staff did not save the device or the packaging, however, the packaging on the other devices in the OR from this time period were reference number 01-3130, lot number 0710021.

Device: Cooling System, Arctic Sun; Model# 2000
Manufacturer: Medivance, Inc.
Problem: Patient experiencing fevers and could not have Tylenol secondary to abnormal liver labs. Arctic Sun cooling machine being used. On a skin assessment, it was noticed that the patient had a red burn-like rash on his upper legs, lateral abdomen/hip region, and on his back. After exam by MDs, conclusion made that this was a cold burn as these areas were in the same places the pads from the arctic sun machine were placed. (Use started in the evening and was discontinued 2 days later, in the evening.) It was charted that the water temp of the machine was below 10 degrees for a sustained amount of time. The machine indicated that in the manual setting (as was used with this pt), it would shut off if the alarms sounded for a low temp. That did not happen in this case. When Dermatology first classified the burn, they were using the term frost bite. In looking at the chart, there were blisters that have opened; some physicians also called the areas lesions. The burns are still being treated (the thigh burns are the most problematic, the others have resolved) with a Mepilex border and Accuzyme ointment. All treatment has been with topical solutions. In the discussions with the vendor, they mentioned they had seen this before when the product was used 10+days, and this was during their FDA approval process. This patient had only been on the device two days when these burns were noted. They have been helpful in providing advice and in troubleshooting, but nothing has been discovered other than the device did not alarm with the sustained low water temps.

Device: Monitor, Physiological, Marquette Eagle 4000
Manufacturer: GE Medical Systems Information Technologies
Problem: All 32 Eagle monitors shut down at once. Monitor techs reported that monitoring of EKG rhythms and pulse oximeter readings had ceased simultaneously, with blank screens everywhere. DASH monitors continued to submit signals. Monitoring restored four and a half hours later. Follow up reveals that the monitors communicate with their respective central stations on various floors and care units via a hardwired network. Investigation has determined that it is most likely that there was a problem with the NIC (network interface card) in one of the Eagle monitors which created unusual traffic on the network that disrupted communication with other Eagle monitors on this network. The network consists of individual sub-networks on each care unit that are then connected to the other subnetworks via a gateway. Only the Eagles that were connected on the one specific gateway were affected by this problem. Once the problem monitor was found, and removed from the network, communication was again established with all other devices on the network.


GASTROENTEROLOGY/UROLOGY

Device: Tubing, Dialysis, CRRT, Diapact; Lot# “G”
Manufacturer: B. Braun Medical, Inc.
Problem: Difficulty with our Diapact Tubing for continuous renal replacement therapy. Not able to reinitiate treatment for an ICU patient. RN spoke with B. Braun Tech Support and she was told “any lot number for the Tubing with a letter ‘G’ is faulty.” He recommended continuing to string the tubing over and over until the system passes. Nurse went through many lines and was never successful getting the machine to pass. We initiated hemodialysis this morning. The Technician told the nurse that he was made aware of this on Friday afternoon. All the tubing at the facility is lot “G.” Requested replacement ASAP (shipped overnight) from sales rep. Unfortunately, the company has not officially recalled the tubing. They have described it as “faulty” and when the warehouse spoke with the company, they said the only tubing available for now is the “faulty tubing” until December 1. I have pursued more to see if they could replace as soon as possible. Will continue to follow.


GENERAL HOSPITAL

Device: Wipes, Disinfectant, Super-Chlor; Lot# DO9, L12 and D25; Catalog# SC110; Wipes, Disinfectant, Super-Chlor XL; Catalog# SC112; Wipes, Disinfectant Gluco-Chlor; Catalog# GC110
Manufacturer: Medtrol, Inc.
Problem: Had been using the Super-Chlor, Super-Chlor XL and Gluco-Chlor bleach wipes (same manufacturer, different size wipe). The packets describe contents including 1:10 chlorine bleach dilution (5200 ppm) as cleaning agents per EPA disinfectant guidelines. Upon testing several packets from different dye lots, found that no bleach was measured.

Device: Gloves, Latex Free, Biogel; Model# 30470; Lot# 07G317
Manufacturer: Molnlycke Healthcare
Problem: Scrub tech found that during use of Biogel gloves and handling a bloody sponge that the blood transferred inside the glove. Scrub tech re-gloved and it happened again. In response, the manufacturer provided RGA (returned goods authorization) and shipping information for return.

Device: Light, Examination, Halex 50SX; Catalog# 6600-0832-8011
Manufacturer: Ohmeda Medical,
A Division of GE Medical Systems
Problem: During a corrective maintenance follow up call, Biomedical noted that all of the radiant warmer/isolette patient exam lights show varying degrees of melting on the top plastic lamp housings. Some were melted to the point of burning completely through the plastic and developing a hole on the top of the housing. The users of the lamps informed us that they were unable to swing the lamp to the other side of the isolette to spot the light at an angle. This was due to the length of the gooseneck flexible arm and the location of the lamp power supply on the isolette. The users were unable to relocate the exam lights because the dovetail clamp knob was small and could not be turned. This forced the users into placing the exam lamp directly under the isolette.

Device: Fast Flow Fluid Warmer, H1000 with H31 Air Detector Tubing, Warmer Set, Disposable Normothermic IV Administration Set; Catalog# D-50
Manufacturer: Smiths Medical ASD, Inc.
Problem: Massive air embolism secondary to device failure. Unit alarmed for air bubble presence and to shut off alarm the system was turned off. When the system is turned off, the Air Detector clamp opens as a default condition. Fluid circuit was pressurized at this time creating the conditions for the embolism.

Device: Cabinet, Medication, Dispensing, AcuDose-Rx; Model# Main Cabinet IIT
Manufacturer: McKesson Automation Solutions
Problem: The AcuDose cabinet locked up and the critical care unit (CCU) staff members could not get the required emergency medications. The touch screen displayed “Cabinet Errors.” Since this was after hours, an on-call pharmacy technician had to come in to reset the machine. In the mean time, CCU staff had to go to both the ED and the PACU for the medications required for an emergency intubation of a child.


GENERAL SURGERY

Device: Vacuum Assisted Closure Device, V.A.C. ATS Canister with Gel; Lot# 20006874, 20006554, 20007213; Catalog# M6275063
Manufacturer: Kinetic Concepts, Inc.
Problem: During a routine wound VAC change, the KCI V.A.C. (vacuum assisted closure) ATS Canister with Gel was found to have white powder spilled throughout the device. The wound vac setting/alarm was checked for clamp settings or blockage. The isolyser bag inside the canister must have broken and the canister, according to the nurse, will not function with the powder inside. The faulty canister was replaced with a new canister with the isolyser bag still intact. Stock was checked for other canisters with isolyser bags that were leaking isolyser and four were found and removed for return to KCI.

Device: Catheter, Cryotherapy Perc 17 Oblong; Lot# 07-0035
Manufacturer: Endocare, Inc.
Problem: The probe from the cryomachine was placed in the patient’s lung. The device was activated and freezing began per the doctor’s protocol. During the procedure, the physician noticed that the shaft of the probe began to freeze. The patient developed frostbite at the entry site and the physician placed a warm saline filled glove at the sight to warm the tissue. At the end of the procedure the patient’s skin looked intact.

Device: Catheter, Drainage, Total, Abscession; Lot# 921495
Catalog# 14000803; Other Device# Locking Pigtail Catheter 8 French
Manufacturer: Angio Dynamics, Inc.
Problem: This is to report a packaging issue. Patient to have a lymphocele drained. The pigtail catheter was placed and medical grade ethanol was instilled to sclerose the area. Patient was repositioned several times to distribute the ethanol. When the catheter was removed, the tip was broken off; 2-3 cm of the tip was embedded in the patient. The tip could not be retrieved. When the package was examined it was noted that there was a warning that the catheter should not be used with alcohol. We recommend that the warning be printed in larger letters, possibly in a different color in order to be more easily detected by the user.


OB/GYN

Device: Controller, Ablation, Endometrial, Thermachoice II; Model# EAS200; Catheter, Ablation, Endometrial, Thermachoice III
Manufacturer: Gynecare Worldwide, A Division of Ethicon, Inc
Problem: Pt underwent D&C with ablation, without known incident. Pt presented 5 days later with fever and pain. Pelvic exam revealed white area of tissue on cervix and posterior vagina, believed to be thermal injury from the thermal ablation procedure 5 days earlier. Patient required hospitalization, pain management, estrogen cream and follow up observation. Long term implications unknown at this time.


OPTHALMIC

Device: Kit, Vitrectomy, 25 Gauge Total Plus Pak & Probe; Lot# 6030726x-2006-12, 6023608x-2006-08
Manufacturer: Alcon Laboratories, Inc.
Problem: Trocar and sleeve went in eye without difficulty; when placed the probes in they got stuck, surgeon had to pull and tug to get out. When the product came out the sleeve and probe came together, the probe was found to be stuck to the sleeve; retinal detachment of the eye occurred requiring additional surgery.

Device: Kit, Vitrectomy 25 Gauge Total Plus Pak & Probe; Lot# 7031027x-2007-10
Manufacturer: Alcon Laboratories, Inc.
Problem: Trocar & sleeve inserted into the eye; could not pull trocar out; described as “felt like there was narrowing of the sleeve” and the sleeve would not come out; surgeon had to tug to get it out. Outcome unknown at this time.


PHYSICAL MEDICINE

Device: Electrodes, Iontophoresis PerformaVE
Manufacturer: Patterson Medical
Problem: Patient received iontophoresis treatment to R arm. The medication used with the therapy was dexamethazone 4mg/ml. The skin was prepped per manufacturing recommendation. Cleaned under both dispersive and treatment sites with the supplied alcohol prep pad, and allowed to dry. The settings used were 80mA at 4.0 current. When disposable pad was removed a quarter sized burn was noted. Pt subsequently developed a blister followed by dark green scab formation. The area required sharp debridement and treatment with Accuzyme. Clinical Engineering department assessed the machine and did not identify a malfunction. One of two recent incidents. * Unknown lot number, device and packaging was not saved. The machine was returned to the company through the sales rep and all of the current stock of electrodes was switched out.

(FDA Note: In the other incident referenced above, the treatment settings are noted to be 70 mA at 2.5 current, the device identifiers are PerformaVE
model #5543-11 and lot #10909, and the patient developed a blister under the disposable pad that resolved without treatment.)



RADIOLOGY

Device: MRI, Magnetom Sonata; Model# 7104719; Tansfer Position Board, Exactrac Patient Tray
Manufacturer: Siemens Medical Solutions USA, Inc.; BrainLab, Inc.
Problem: Patient having an MRI prior to radiation therapy treatment. Patient was asked to lie on a carbon fiber and styrofoam positional immobilization board, which is MRI safe. After the scan was completed, the patient reported a burning sensation around their shoulder area. There were three areas of concern: one small black area anterior to two blisters located just posterior to the clavicle.

Device: Simulator, Radiation, Elekta Nucletron; Model# 118021-01
Manufacturer: Elekta Inc.
Problem: A patient with incurable lung cancer and bronchoscopy showing an approximately 90% obstruction of the right mainstem bronchus due to tumor. Radiation Oncologist recommended urgent radiation in order to prevent a complete obstruction of the right lung as well as to reverse the hemoptysis. The intention of the physician was to irradiate the right mainstem bronchus, the subcranial lymph node region and a portion of the mediastinum. The radiation beam was placed on both the mediastinum and subcranial lymph nodes as planned. However, the left mainstem bronchus was included instead of the right. The first portion of the simulation was performed by the resident, who approved the images under fluoroscopy. The X-ray films were additionally reviewed by the attending radiation oncologist and later reviewed by dosimetry (planning specialists), physicists at routine chart checks, and physicians at our routine chart review. All of these efforts failed to detect the error. A Radiation Therapy student was reviewing the chart, and noticed the discrepancy between the intended area and the treated area. Treatment was immediately discontinued at a total dose of 2500 cGy (at 250 cGy per day) after completing 10 of 14 planned treatments.

The patient was not harmed by this “event,” in fact their symptoms improved. Since then, the patient has been resimulated and treatment is currently being given to the right mainstem bronchus. A CT Scan was used to reconstruct the initial treated volume. Clinical Engineering observed the “reverse” button on the control panel of this simulator. This functionality of this button has been discontinued at this moment. A letter was written to the manufacturer asking for a plan of action. The site is waiting for the manufacturer’s response at this time.


LABORATORY/DIAGNOSTIC TESTS

Device:Analyzer, Chemistry, Advia Centaur; Model# IRL50090518
Manufacturer: Siemens Medical Solutions Diagnostics
Problem: Sensor malfunctions on instrument performing Troponin assay causing the instrument to run out of WASH I and not function properly. Technologist realized instrument problem when quality control was not acceptable and higher than normal number of positive results. Testing transferred to another instrument, and instrument not utilized for patient testing. Instrument engineer was already on site for an unrelated problem and was able to diagnose this problem. The instrument sensor will be replaced and the instrument will be QC’d and put in to use if it passes testing.


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Updated February 1, 2008

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