Highlighted Reports
MedSun: Newsletter #27, August 2008

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 May 1 through May 31. 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.


NEUROLOGY

Device: Liquid Embolic System; Onyx 34
Lot# 4725495
Catalog# 105-7100-080
Manufacturer: EV3, Inc.

Device: Liquid Embolic System; Onyx 34
Lot# 3904009
Catalog# 105-7100-080
Manufacturer: EV3, Inc.

Device: Microcatheter; Echelon
Manufacturer: EV3, Inc.

Problem: Patient undergoing stage III embolization of left frontal AVM, arterio-venous malformation. The microcatheter was placed from the femoral artery up into the head in the AVM. During the gluing process, the microcatheter became adhered into the AVM and was unable to be removed. The microcatheter was cut so that 3/4 of the microcatheter was in the patient's arterial system. The remaining portion will be removed at a later time following discharge from this admission. In previous MAUDE reports the manufacturer warns to not allow more than 1 cm of Onyx to reflux back over catheter tip. Reportedly, less then the recommended amount of Onyx was used in the procedure.


OBSTETRICS/GYNECOLOGY

Device: Uterine Manipulator/Retractor; VCARE
Lot# 0801281
Manufacturer: ConMed Corporation

Device: Robotic Surgical System
Manufacturer: Intuitive Surgical, Inc.

Problem: During a laparoscopic robotic assisted procedure, the VCARE broke down in parts into the patient's uterus. The physician scrubbed in, removed the uterus and all of the remaining parts of the VCARE (Uterine manipulator) through the vagina. No additional intervention was needed at the time.


ANESTHESIOLOGY

Device: Bag, Resuscitation
Model# VN4100
Manufacturer: Ventlab Corp.
Problem: Patient experienced laryngospasm in the OR, which was controlled with medication. She was taken to the recovery room, where she again went into laryngospasm. The CRNA tried to open the patient's airway, but she was obstructing. The team started to bag the patient with a pediatric-sized resuscitation bag. There was no chest rise. The bag was replaced with another pediatric-sized resuscitation bag. That one also resulted in no chest rise. The team switched to an adult sized resuscitation bag made by a different manufacturer. The patient was intubated, and they were able to bring her saturation rate back to normal. The whole event lasted approximately 90 seconds, and the patient suffered no sequelae. After the event, the team examined the two bags, and one had a 0.5 cm tear in it. The other had a hole near the connection to the circuit. All the bags by this manufacturer were inspected, and the rubber appears to be deteriorating. The rubber is thin, and exposure to the heat of the lights on the headrail where the resuscitation bags are kept may be a contributing factor to their deterioration.

Device: Holder, Endotracheal Tube; Anchor Fast Oral Endotracheal Tube Fastener
Model# 9799
Manufacturer: Hollister Inc.
Problem: Oral ET fastener was in place on patient. While patient was being repositioned, ET fastener broke. The tube holder was firmly on the ETT and the holder was firmly secured on face, but the white plastic connection broke off and the patient became extubated.

Device: Anesthetic Gas Module; Intellivue
Model# G5
Manufacturer: Phillips Medical Systems
Problem: The CO2 monitor was reading 34-0-34-2-34-0 instead of a steady 34. When a blood gas was sent, it confirmed a CO2 level of 34. This is a recurring problem with this monitor. The hospital has had 5 occurrences in the last week. It is unclear what is causing the problem. Of note, this is being used in the OR in addition to the ICU's and we're only experiencing this problem in the OR setting.

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Manufacturer response for anesthetic gas module, Intellivue
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The Phillips representatives are uncertain what is causing the variation. They state that the problem may be due to the use of a different manufacturers’ sample tubing instead of Philips sample tubing. This has been known to cause a problem with falsely low ETCO2 readings. Philips is shipping sample tubing to the facility to see if this solves the problem.


GENERAL & PLASTIC SURGERY

Device: Cuff, Tourniquet; Zimmer 34" Tourniquet Cuff
Model# 60-7070-106
Lot# 137475
Catalog# 60-7070-106
Manufacturer: ASCENT Healthcare Solutions
Problem: 34" Zimmer leg tourniquet cuff which had been reprocessed and packaged by Ascent Healthcare Solutions x1 deflated after being up for a few minutes, it appeared to be leaking, possibly from the connection of the hoses to the cuff. The procedure was done without the tourniquet.

To read a January 2007 Safety Tip entitled, "FDA Safety Tip: Pneumatic Tourniquet Cuffs with a Tourniquet," please visit:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/news/newsletter.cfm?news=11#1

Device: Dermatome, Electric
Manufacturer: Zimmer, Inc.
Problem: The patient was undergoing a skin graft to the right ankle from the left thigh. The Padgett blades that were being used with the Zimmer Dermatome were not compatible with the Dermatome, which resulted in a deep cut to the patient's left thigh. The blade was switched out with another Padgett blade and it too was incompatible. This resulted in another deep tissue injury to the patient. Both lacerations were sutured.

Please see recent article describing these issues posted in July 2008's Newsletter online available:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/news/newsletter.cfm?news=26#4


PHYSICAL MEDICINE

Device: Aid, Transfer, Bathroom; Lumex Portable Bath Bench/Transfer Board
Lot# A080131
Manufacturer: Graham Field Health Products, Inc.
Problem: Patient's family member called and reported that the back of the transfer bench would not lock into place. We pulled another transfer bench to replace this one and found the same problem with the entire shipment. In another one of our home health medical equipment locations, the same equipment was inspected and found to have the same problem. All locations have been instructed to isolate this equipment. The manufacturer's representative has been notified.

Device: Cold Therapy Unit; DonJoy Iceman Cooler
Model# 1100
Lot# 112907-01B
Manufacturer: DJO, LLC
Problem: Staff reports that they were applying the cooling unit at the end of the surgical case. When they turned the unit on, it began leaking from the point where the blue tubing exits the main cooling unit. Staff was concerned that it could have contaminated the fresh surgical site. They also report that they have had the same problem with this device in the past.

Device: Heat Therapy Unit; T Pump
Model# TP 200
Manufacturer: Gaymar Industries, Inc.
Problem: Patient admitted for redo repair of his paraesophageal hernia, and Nissen fundoplication. He was taken to surgery and given general anesthesia with an epidural for post-operative pain management. Post-operatively he complained of neck pain. A heating pad and PT were ordered by the physician. He was given a pad for heat the day after surgery. Two days later it was noted his back was red with blisters. The reddened areas and blisters were in the shape of the pattern on the pad. The patient states he slept on the pad but could not feel it burning because of the epidural.


GENERAL HOSPITAL

Device: Catheter, IV; BD Insyte Autoguard
Lot# 7348099
Manufacturer: BD Insyte Autoguard
Problem: An 18 gauge Insyte Autoguard was being inserted into the patient's arm. When then the retraction was deployed using the push button, the green hub of the IV was seen dangling from the patient's arm/insertion site. The catheter was "missing." The catheter could not be located at first. The patient was x-rayed and the catheter was not located. The BD representative came out and was able to see with microscopic lenses that the catheter had actually retracted back into the retraction device of the IV.

Device: warmer, infant;
Model# RW82-1
Manufacturer: Drager Medical Systems, Inc.
Problem: Infant warmer ignited while unit was in the Operating Room pending delivery of the infant. The unit was in operation but infant was not in the bed. A manufacturer's representative came to the facility to replace parts on the damaged unit and will be replacing the heater elements on all units in our facility. The hospital's Biomedical Engineering Department has replaced heating units on four other warmers at the facility in the past year, which they consider a high failure rate.

Device: Incubator, Infant; OmniBed
Model# 600
Manufacturer: Datex-Ohmeda
Problem: The Air Mode was being used to preheat the OmniBed incubator while awaiting the infant's return from surgery. When the infant was placed in the OmniBed, the bed was not put into Baby Mode. This caused the OmniBed to maintain an air temperature of 41.7 degrees C (107 degrees F). This elevated air temperature resulted in an increase of the infant's axillary temperature.

Device: Thermometer, Digital
Model# KD-192
Other Device # P/N: 8219200015
Manufacturer: K-JUMP HEALTH CO., LTD
Problem: Parents of infant used CVS brand digital thermometer at home to check child's temperature. Temperature read as 102.5. Family presented to ER with infant. In ER setting temperature obtained was 98.9. Sepsis work-up performed, including multiple lumbar puncture attempts. IV antibiotics administered. Parents brought thermometer in from home. When tested, the infant temperature was 103 on the CVS thermometer and 99.2 on the hospital thermometer.

Device: Incubator, Infant; Airshields
Model# C2000
Manufacturer: Draeger Medical, Inc.
Problem: Infant being assessed when nurse smelled electrical smoke. Smoke seen above isolette. Infant removed from isolette immediately and placed in a clean isolette. Change nurse notified. Security called. Hospital biomedical called and notified. Biomedical sheet filled out and isolette taken to dirty utility room to be cleaned. No problems with infant.

Device: Infusion Pump; Outlook
Model# Outlook 100 - 13215
Manufacturer: B.Braun Medical, Inc.
Problem: Our hospital recently began using B.Braun's Outlook 100 Infusion Pumps. These pumps have a programmable drug library. During the course of implementing the pumps and continuing to present we have had multiple (23+/-) instances of the pumps "losing" their drug libraries (i.e. the pumps default to their factory preset and prompt the user to enter the dosing information rather than allowing the user to pull information from the drug library). This does not impact the patient as the RN's can revert back to programming the rates manually, but our staff have been trained to utilize the libraries which is the safest method. In troubleshooting the issue, B. Braun did send a software upgrade (version 151510) which has not fixed the problem (with the software upgrade, we no longer see error 75, but we now see error 74, and the pumps still “lose” their drug libraries). B.Braun has suggested this is possibly a result of the pumps running low or out of battery power. Our staff has been pulling these pumps from service, have sent them to Clinical Engineering for "re-loading" of the software and the issues have not subsided. Our Bio-med does indicate they have had several pumps which have run out of battery power completely (purposefully while trying to troubleshoot the problem) and these pumps have retained the library despite the battery being depleted. B.Braun is now in the process of replacing the batteries in our pumps as we may have gotten a bad batch of batteries.

Device: Patient Bed; Versa Care
Model# P3200
Manufacturer: Hill Rom Company, Inc.
Problem: The right intermediate side rail did not latch in raised position. This caused the patient to fall out of bed when she was holding on to the bed rail to turn in bed.

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Manufacturer response for Patient Bed, Versa Care
======================

The manufacturer's representative at Cape Fear Valley Medical Center was already aware of this problem with other beds in this facility and was in the process of replacing these latches on other beds. Unfortunately his job was not completed prior to this incident happening. Bed was removed from service until repair made. He states that the patient right intermediate side rail will not latch in the raised position due to latch pins that will not fully extend.


CARDIOVASCULAR

Device: Defibrillator, External
Model# M-series
Manufacturer: Zoll Medical Corporation
Problem: Morbidly obese post-op patient had witnessed cardiac arrest. Underwent five unsuccessful rounds of ACLS medications and defibrillation using the Zoll M series biphasic defibrillator charged to 200 joules (the maximum) for pulseless ventricular tachycardia rhythm. The code team obtained and applied a different manufacturer's biphasic defibrillator that allows 360 joules defibrillation. The rhythm was captured and converted to normal sinus rhythm with a single biphasic shock at 360 joules.

Device: Cannula, Vascular, Cardiopulmonary Bypass; Soft Flow Aortic Cannula
Lot# 0495730
Manufacturer: Terumo Medical Corporation
Problem: The cap did not tear easily to open the blood flow and enable connection to bypass cannula. The procedure calls for insertion of the aortic cannula, suturing it in place and removal of cap for connection to bypass. The surgeon attempted to tear the cap off for approximately 2 minutes and eventually successful. The surgeon had to use the scalpel to pry it off. There was no patient harm.

Device: Instrument, Surgical, Cardiovascular; PerfectCut
Lot# 3099303H
Manufacturer: Quest Medical, Inc.
Problem: PerfectCut lancet failed to cut in a 4 mm, cross-cut pattern. The lancet made a linear cut instead, approximately 6 mm in length, thus cutting a larger hole than necessary in the aorta. Per the surgeon, this could have lethal to patient. Patient suffered minor harm.

Device: Injector, Contrast; Angiomat Illumena Injector
Manufacturer: Covidien Mallinckrodt
Problem: Clinical Engineering was notified of a problem with a Mallinckrodt Illumena injector used in the cath lab. The cath tech stated that the injector had blown the catheter off of the syringe during a “test” injection to verify the position of the catheter. CE took the injector “out of service” and gave them a spare injector to use. CE called Mallinckrodt service and a technician came in to check the injector the next day. CE and the service tech gathered information from the cath tech on the event and tested the injector. The cath tech stated that he was using the “fill-control bar” for the test injection and that the stop-cock on the manifold was closed during the test injection and should have been open. The service report states that the service tech verified that the pressure limiting system in the injector was operating properly and that when the “fill-control bar” was used “there was no pressure limiting”. He felt that the “fill-control bar” should not be used for injection. I verified that the Instruction manual states that the “fill-control bar” can be used for “test” injections. I called Mallinckrodt to question whether the “fill-control bar” should be used for a test injection if there was not pressure limiting and Mallinckrodt was also concerned about this situation. They strongly recommended that the “fill-control bar” should NOT be used for a “test” injection until they can do testing and verification of this product. The Director of Cardiology was notified and the Cardiology and Radiology staff received education. Manufacturer response for injector, Mallinckrodt, they will check other devices.


OPTHALAMIC

Device: Ophthalmic Gas, SF6; Sulfa Hexa Fluoride (SF6)
Lot# 623308
Catalog# 8065-7970-01
Manufacturer: Alcon Laboratories, Inc.
Problem: The physician performed the following procedure due to a flash related traumatic macular hole in right eye, reducing vision to 20/200: 25g pars plana vitrectomy, Indocyanine green assisted membrane peeling, fluid air exchange, and injection of 30% SF6 gas (right eye). 25g sclerotomy sites X2 were used as well as one 20g site. The 20g site was closed w/7 ovicryl. According to surgeon, SF6 gas dissipated faster than it should, which could have resulted in the failure of the macular hole to close. A second surgery was performed by the same physician approximately 5 months later for macular hole, right eye. Surgery: 23g pars plana vitrectomy, fluid air exchange, injection 20% C3F3 gas right eye. Outcome unknown.


EAR NOSE & THROAT

Device: Bronchoscope;
Model# BF 160
Manufacturer: Olympus America Inc.

Device: Bronchoscope
Manufacturer: Olympus America, Inc.

Problem: The biopsy port and/or channel of two bronchoscopes cultured positive for Pseudomonas putida, Stenotrophomonas and Pseudomonas aeruginosa after a cluster of patients was cultured positive for at least one of the three bacteria. Olympus inspected the scopes and found loose biopsy ports. Prior to this incident, a third party vendor, was engaged in the fall of last year to "repair" the scopes. The third party vendor was also invited to inspect the scopes. During a recent investigation, it was determined that the third party vendor was not able to employ Olympus's standard for biopsy port repair because Olympus considers that information "proprietary." Therefore, the third party vendor attempted to repair the scopes using "industry standards" of which they were aware. Two key issues may be the type of adhesive used to secure the biopsy ports, as well as the "foot pounds" of torque applied to the nut that holds the stem in place. The third party vendor did not have access to Olympus's "proprietary" specifications with regard to these two items. This may have contributed to the loosening of the ports over time and subsequently to the harboring of bacteria.


RADIOLOGY

Device: Computer, CT Stereotaxy Location Detection; iPlan
Model# 109004B
Manufacturer: BrainLab, Inc.
Problem: Brainlab program not working, software not working. The rep for Brainlab was contacted and able to pull up the software on his laptop computer and assist with the case. The surgery was delayed about 45 minutes. There was no patient harm. After the case, the tech installed an updated license on the facility's planning stations to include the required ARC localizer for iPlan Stereotaxy. The system was checked by Biomed and returned to service.


Additional Information:

To read a January 2007 Safety Tip entitled, "FDA Safety Tip: Pneumatic Tourniquet Cuffs with a Tourniquet," please visit:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/news/newsletter.cfm?news=11#1

Please see recent article describing these issues with the Zimmer Dermatome posted in July 2008's Newsletter online available:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/news/newsletter.cfm?news=26#4


MedSun Newsletters are available at www.fda.gov/cdrh/medsun