Highlighted Reports
MedSun: Newsletter #18, November 2007

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 July 1 through August 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.
*2 month period for November Newsletter


Device: Ventilator, EvitaXL
Manfacturer: Dräger Medical AG
Problem: The ventilator displayed "device failure" then shut itself off. The patient was on noninvasive ventilation mode and was taken off the machine promptly by nursing staff and placed on oxygen. The ventilator was replaced with another unit. When Clinical Engineering staff looked at the ventilator, it displayed several error codes: 02.00.002, 10.99.111, 10.99.112, 11.01.011, 12.01.011, and 13.01.040. All these codes have different meanings, but, according to Dräger, when grouped together, they point to an issue with either the air or O2 high pressure solenoid valve. The valve has locked up and possibly caused the -15 volts to drag down, causing the ventilator to go into reboot.

Device: Catheter, Bronchial, Single-Use Nonbroncho scopic Broncho alveolar Lavage Catheter (16 Fr diameter 5.33 mm length) Model# REF 141 Lot# 392141 and 397902
Manfacturer: Kimberly Clark Corporation
Problem: In the process of instilling a Mini-BAL Introducer (part of the nonbronchoscopic bronchoalveolar lavage catheter), the introducer section of the inner catheter tore and disconnected from the site. The procedure was immediately terminated, with no harm to the patient. The Kimberly-Clark representative stated that other users have reported the same issue with the catheter. During the investigation, all catheters in stock were inspected, and several of these were noted to be defective. Defects were associated with two lot numbers. The Respiratory Department and the company determined that for the catheters to be safe for use, each catheter should be inspected prior to use. Any defects should be reported. Within lots 392141 and 397901, 140 catheters were removed immediately, with 45 replaced, and more are being shipped to replace the total number. The company representatives feel that this is an urgent matter, and all appropriate staff have been notified and are mobilized and working diligently to resolve this matter.

Device: CPR Bag Lot# 06184004, 06072004, 06348187, 06345187 Catalog# 10-55187
Manfacturer: Mercury Medical
Problem: The Clinical Engineering Department performs an acceptance test on every resuscitation bag before the product is placed into use by the hospital. Nine bags have recently failed our inspection. The reservoir bags have had several cuts 2–4 inches long. These cuts tend to be located at or near the fitting that attaches to the hand-operated bag.

Device: Humidifier, Ventilator, Water Float in Ventilator Heater Chamber Circuit Model# MR 290 Lot# 061204 1630 DL
Manfacturer: Fisher & Paykel Healthcare Corporation, Ltd.
Problem: Prior to this incident, the ventilator circuitry had just been changed. The sterile water bag had just been spiked to fill the heater/humidifier water chamber. The float that controls the water level was stuck. This caused the water to fill the water chamber and flow up into the circuit to the patient, causing the patient to desaturate and become bradycardiac and cyanotic. The patient was immediately taken off the ventilator and manually ventilated until fully recovered, and the water chamber was replaced. Two days later, the malfunctioning equipment was reported. The quality team is following up, and they have reported the incident to the manufacturer. According to our Respiratory Therapy Department, this type of failure is not easily identifiable until the sterile water is added to the circuits, which generally occurs after the patient is on the ventilator. Additionally, depending upon the speed and nature of the defect, it may take anywhere from seconds to hours for the water to fill the heater chamber to a level that will direct water toward the patient.

Device: Ventilator Model# 840
Manfacturer: Puritan-Bennett Corporation
Problem: The ventilator alarm and external room alarm were sounding. The patient's ventilator read "INOP." The patient was immediately removed from the ventilator and bagged with 100 percent oxygen. The RN then assumed responsibility for ventilating the patient while the respiratory therapist exchanged the ventilator. The patient’s vital signs were stable throughout incident. The ventilator was pulled from service. A problem was found with the CPU board, which was then replaced.


Device: Hemodynamic System, Catheterization, SE Horizon Model# Console 9000
Manfacturer: Mennen Medical Ltd.
Problem: During a cardiac catheterization procedure, the Mennen hemodynamic monitor failed and would not show any EKG tracing or heart rate. This equipment had screen lockups with the error message "no connection from CFE (catheterization laboratory front end)" during at least four other catheter laboratory procedures earlier this year. The patient was not harmed. A portable monitor was immediately used for pulse and EKG monitoring, and the Biotechnical Department has been unable to duplicate the screen lockups and the disappearance of EKG tracing and heart rate. The machine would work if the CFE button were reset. A few months ago, a Mennen field service engineer applied a patch for Sun Blade systems that use dual video cards. One is built onto the mother board, and one is added to the video card. Since the patch was applied, we have continued to have the same problems intermittently on five pieces of this equipment.

Device: Seal System, HEARTSTRING II Proximal Seal System Model# HSK-2038 Lot# 7040581, 7020681, 7041181
Manfacturer: Guidant Corporation
Problem: The patient was undergoing a coronary artery bypass graft (CABG) procedure. A total of seven Guidant HEARTSTRING II Proximal Seal System devices were opened for the case, and only one was used. Two of the devices were unraveling when opened. Three were folded and inserted into the deployment device per the manufacturer's recommendations, but these unraveled prior to use. One was placed and ready for deployment, but it did not deploy out of the device. The seventh device was successfully inserted and used in the patient.

Device: Guidewire, Vascular, Wholey Hi-Torque Modified J Lot# 7012691 Catalog# 50110
Manfacturer: Tyco Healthcare/Mallinckrodt
Problem: During a coronary angiography, left heart catheterization, left ventriculogram, and arterial and venous bypass graft angiograms, the 4 French 12 cm sheath introducer was inserted in the right femoral artery. The patient has peripheral vascular disease. The 0.035 mm J tip 145 cm guidewire was inserted, followed by a 4 French straight pigtail diagnostic catheter and 4 French JL 4.0 diagnostic catheter, 4 French 3 DRC diagnostic catheter, and a 4 French internal mammary diagnostic catheter. During the procedure, the distal end of the Wholey guidewire separated at the gold connector, and this was visualized on fluoroscopy. The guidewire did not come apart. It was removed and replaced with another 0.035 Wholey 145 cm guidewire, and the procedure was completed without complications. The patient was discharged to home 1 day after the procedure in good condition. The guidewire, packaging, and an unused sample from the same lot number were saved for investigation by the manufacturer.

Device: Transducer Kit, Blood Sampling, TranStar Lot# 36K16M085, 1147039 Catalog# MX9537T
Manfacturer: Smiths Medical
Problem: Three events were reported in which the yellow blood-drawing port came apart from the product when being used in the NICU. In one incident, the syringe also disconnected from the tubing. Products from two different lot numbers were being used at the time of the incidents, so the specific lot number for each product could not be identified. There was no patient harm in any of the reported incidents, and the manufacturer is aware of and is investigating the reported incidents. No further information is available at this time.

Device: Monitor, Physiological Dash 5000
Manfacturer: GE Medical Systems Information Technologies
Problem: Twenty-eight GE Dash 5000 cardiac monitors were purchased approximately 18 months ago. The monitors also track oxygen saturation. The monitors pickup and alarm at the slightest modification, regardless of duration, suggesting that the neonate is sicker then he/she really is. We have been working with GE seeking a longer delay that will verify if the O2 saturation is simply a spike or a longer O2 decrease. GE acknowledges the problem and has advised us that they have to run any change past the FDA, and that it will be October before a fix is available. This issue causes a possible longer length of stay, worry for parents, and additional tests.

Device: Catheter, Intra-Aortic Balloon, Ultra 8 Lot# MF 7033808 Catalog# IAB-05840-U
Manfacturer: Arrow International, Inc.
Problem: The patient went to surgery for a mitral valve replacement. The patient returned to surgery later in the afternoon with postoperative bleeding at the operative site and then returned to the surgical intensive care unit on an intra-aortic balloon pump. During the night shift, the balloon console alarmed continuously. The console was changed two times without resolution of the problem. The physician was called to the bedside and was about to change out the intra-aortic balloon catheter because it was working intermittently for about 10 seconds at a time. The patient underwent cardiac arrest during the time the balloon was intermittently functioning. The patient was resuscitated, and a new balloon was inserted. Currently, the patient remains unresponsive in critical condition and appears to have sustained permanent neurological damage. We have had several other reported issues with this same fiber-optic catheter over the last several months (balloon failures, various alarms), which have recently been reported to the device manufacturer. We have obtained lot numbers from the shipments several months ago. If these lot numbers are needed, we have them, but we have not saved the outer wrappers from the devices involved in these past events to confirm actual lot numbers. Arrow International, Inc., stated that the company has not had a reportable number of complaints involving this product. Their representatives feel the lack of wire reinforcement in this particular catheter may be leading to kinking, thus generating the alarms. The company has offered additional troubleshooting training for users.

Device: Electrodes, ECG, Neonatal Lot# 704710, 708207 Catalog# 13953A Other Device# RMA MC07071605
Manfacturer: Philips Medical Systems
Problem: The ECG neonatal electrodes have bright aqua/baby blue-colored spots on them, which were caused by bare metal wire fragments in the gel. The problem was immediately obvious because of the change of color from white to bright blue on the pads, so the electrodes were not used; however, the concern is that if they had been used, they could have damaged the extremely fragile skin of premature or newborn infants. This color change occurred once before, approximately 14 months ago, and was reported to the company.

Device: Syringe Kit, Contrast Injector, ACIST Lot# 0307B, 0047B Catalog# SKU 014612 Other Device# CMS 2000 Injector
Manfacturer: ACIST Medical Systems, Inc.
Problem: Contrast injector syringes are fracturing at the contrast port. This has occurred several times. The manufacturer is aware of this problem and is evaluating the reason for the failures. When using the A2000 syringe kits for the ACIST Angiographic System it has been suggested to use a 3Fr–5Fr catheter, flow rates of slower than 10 ml/second, and rise times longer than 0.6 seconds.


Device: Biopsy Gun, Inter V BioPince Model# 360 1080-01 Lot# 71691HOM
Manfacturer: Angiotech
Problem: Normally, there are two core biopsies acquired for an ultrasound guided liver biopsy. In this case, six attempts were made with three separate core biopsy instruments, with no samples obtained. The fourth instrument did obtain a small but satisfactory core. One more attempt was made with the same instrument to obtain a second satisfactory core, but it again came up dry. The representative has contacted the company representative several times without a reasonable resolution. Since more than one patient incident of this type has occurred while using this biopsy instrument, the physician's assistant has requested that no more core liver biopsies be scheduled until this problem is resolved. There has been no patient harm. We do not have the device, but they came out of the lot numbers that we still have. (A similar MedSun report was received during the selected reports timeframe involving the same model device and Lot# 70311E20.)

Device: Dialysis Machine, Continous Renal Replacement Therapy PRISMAFLEX
Tubing Set, Dialysis Model# M100 Lot# 06L1569
Manfacturer: Gambro Renal Products, Inc.
Problem: The patient was receiving continous venovenous hemodialysis (CVVHD) in his room when the alarm sounded. The RN answered the alarm, which displayed "Low Pressure Alarm" on the screen, with instructions to check the patient and check for connection problems. The RN verified that the patient was still properly connected to the CVVHD machine and that all connections were correct. At this time, the RN hit “Continue,” as directed by the CVVHD machine after verification of the connection to the patient. Approximately 5–10 minutes later, the CVVHD machine alarmed again. Another RN on the unit went into room and called out for help. The patient's RN then went into room. There was blood on the floor and the machine displayed "Patient Self-Disconnect"; however, the CVVHD machine tubing never became disconnected from the patient. The RN assessed the patient. The patient was hemodynamically stable throughout. The RN disconnected the patient and stopped the machine, as directed by the dialysis RN. The RN found a small white piece of rubber under the patient's bed and collected it in a sterile cup in case this is part of the CVVHD machine that was faulty and leaking blood. The patient remained stable throughout. We believe that the filter partially clogged, causing pressure to build up and the tubing set to fail. Gambro will evaluate the product.


Device: Patient Lift, Golvo 7007 ES Other Device# 2000010
Manfacturer: Liko, Inc.
Problem: The patient was ready for discharge to home status after percutaneous endoscopic gastrostomy tube placement. The patient was unable to stand due to a history of strokes, so the staff used lift equipment to get the patient from the bed to her wheelchair. Staff report that as the patient was lifted from the bed and to the chair, the sling started to slip out from under the patient, allowing her head to fall back. The staff tried to ease the patient to the floor while she was still partly in the lift device, but her head fell back and struck the bottom support beam of the lift approximately 2 feet from the floor. The patient sustained a lump to the back of her head, but she had no loss of consciousness, and her vital signs were stable. She had a history of coumadin use. The physician was notified, and a head CT scan was done, and the results were normal. The patient was admitted for observation and was discharged the following day to home. Her neurological assessment remained unchanged throughout the observational stay. The lift equipment and sling were inspected, and both functioned appropriately. We believe this is user error. The only way we and the representatives were able to reproduce this event was by applying the leg straps to the sling bar first instead of the shoulder straps. Also, the sling size appears to be too large for this patient, which contributed to the event. Although staff were trained and experienced in using this equipment, they felt that it would be helpful for the manufacturer to consider making the shoulder and leg loops on the sling different colors as a secondary visual cue to make sure the device is used according to the manufacturer's instructions.

Device: Tubing, IV, Patient Controlled Analgesia, Epidural CADD Yellow-striped Administration Set Lot# 126x46 Catalog# 21-7339
Manfacturer: Smiths Medical
Problem: The patient-controlled analgesia (PCA) epidural tubing was attached to an IV pump. The Assistant Director of the Postanesthesia Unit is familiar with the epidural and IV PCA medication tubing problem because she had similar problems in the last hospital where she worked. The ends that connect to the catheter on the tubing for administration of the epidural and on the IV PCA medications tubing are very similar. They have identical male luer lock connectors that easily fit into the connector on the epidural or on the IV PCA catheter. The epidural tubing has two yellow stripes running along its length. The IV PCA tubing is clear. If the epidural tubing is rotated, there are positions at which the yellow strips “disappear” and the tubing looks clear. The middle portions of the two tubings are different, but sometimes these sections are hidden by the bedding or the patient’s position. Given the consequence of a patient’s receiving a large IV bolus of bupivicaine, potentially lethal cardiac arrhythmia, and the fact that this problem has already occurred with two patients, we are considering implementing a Timeout policy, which would allow us to verify that we are giving the correct medication via the correct route when epidural or IV PCA pain medications are being set up.

Device: Pump, Syringe, Medfusion 3500
Manfacturer: Smiths Medical
Problem: The patient was an active toddler receiving milrinone at a rate of 0.5 mcg/kg. The patient's mother left the room, and when the nurse went to check on the patient, he/she found that the syringe of milrinone had been removed from the pump by the patient and was in his hand. The nurse verified and confirmed that no extra medication had been delivered. This pump does not lock; instead, the syringe is clamped into the pump. To avoid this in the future, a locking device attachment that could be affixed to the pumps would be helpful for use in the pediatric population.

Device: Pump, IV Symbiq Infusion System
Manfacturer: Hospira Global Medical Affairs
Problem: There have been intermittent problems with the Symbiq Infusion System in which the pump stops infusing, the alarm sounds, and an error message (S321/S421) appears on the screen. This problem was reported to Hospira. According to Hospira, when the device triggers this alarm, the device is designed to stop infusing at the affected channel, and a continuous, high-level alarm will sound until the clinician responds. There have been no adverse outcomes related to this malfunction. Staff removed the malfunctioning device from service and obtained another pump.

Device: Pump, IV, Module ALARIS Model# 8100
Manufacturer: ALARIS Medical Systems, Inc.
Problem: The channel through which Levophed was running turned off by itself with no alarm or warning. The patient's blood pressure dropped to 60/20. The cardiac monitor alarmed, which is how the malfunction was discovered. Medication was restarted.

Device: Bed, Hospital, Florence Electric Bed Model# FL23E
Manufacturer: Stryker Medical
Problem: The hospital had ordered two new "junior" (pediatric) electrically operated beds. When delivered, it was noted that the beds have two accessory plug-ins for patient equipment at the foot. These patient device accessory outlets are not labeled as to any safety concerns. This manufacturer has adult beds that have accessory outlets that require labeling not only for electrical safety but also for use safety, such as "Do not use for life saving equipment," which indicates that the outlets are not battery-supported. No such labeling is on the pediatric bed. It appears that the design of the bed would indicate there was no battery, but this is presumptive knowledge on the part of the user.

Device: Needle, Huber, SafeStep Lot# D630505 Catalog# LH0030
Manufacturer: Specialized Health Products, Inc.
Problem: The product malfunctioned on five occasions. The second event was an occlusion; the others were leaks where the tubing connects to the needle. Air entered the tubing during a blood aspiration during the most recent event. The manufacturer is having problems with some of the products made in 2006 and is swapping out these products.

Device: Needle, Huber, MiniLoc Safety Infusion Set Model# 0632010
Manufacturer: Specialized Health Products, Inc.
Problem: The patient was discovered in bed with her MiniLoc Safety Infusion Set huber needle that is used to access her implantable port separated. The patient was receiving 5-FU (chemotherapy drug) at the time, and there was some of the chemotherapy on her bra, gown, and bedding. The patient's old huber needle was removed. This is the tenth incident involving this same model of huber needle in the past 6 months at our hospital. One of the devices was sent to the manufacturer, and another one is at our facility. The packaging was thrown away in all instances. Inspection of all devices showed that the tubing portion of the MiniLoc became unglued from the luer lock portion, causing medication to spill out of the tube onto the patients. None of the patients involved was reported to be combative, so it appears that the tube just slipped out of the luer lock portion after the glue dissolved in some way. Because these devices are primarily used for chemotherapy drugs, the drugs could be caustic to the skin and therefore pose a patient safety risk. The manufacturer was contacted and we were told that their representatives do not know why this is occurring, and that they need to do more research. The manufacturer sent us replacement devices in that instance.

Device: Tubing, IV, Outlook 200 Model# 200
Manufacturer: B. Braun Medical Inc.
Problem: An antibiotic was hung as a piggyback medication into primary line, which was on a pump. The pump was running in piggyback mode with 223.4 ml to be infused. The primary bag that previously held 200 ml now was at 480 ml. The pump settings and bag height placement were correct. The upper backcheck valve of the tubing was found to be folded over. It appears that the backcheck valve of the primary IV set failed, and the antibiotic ran into the primary IV instead of going into the patient.

Device: Tubing, IV, Extension Set, Mini Bifuse Lot# 36j25m032 Catalog# MBF30
Manufacturer: Smiths Medical
Problem: The patient's Medex Mini Bifuse disconnected from the IV tubing. The Mini Bifuse was connected to the central venous line (CVL). This disconnection caused blood to flow out of the CVL. This was the second patient today whose Medex Mini Bifuse disconnected by itself. Product issue is the question.

Device: Bed, Hospital, Crib Model 2000
Manufacturer: HARD Manufacturing Co., Inc.
Problem: Staff noted that the wheel on the crib would not turn without significant effort. Upon closer examination, the Biomedical Department discovered that three out of four of the screws had fallen out of the bracket that holds the wheels to the frame of the crib. HARD Manufacturing was contacted and recommended that a threadlocker be added to all wheel bracket mounting screws on all affected cribs. (It appears that this was not done during the assembly process.) Our facility has 10 of these cribs. All were checked. Four, including this one, had screws that fell out. A threadlocker was added to all of the screws. No harm to any patients.

Device: Pump, IV, Module PC Model# 8100
Manufacturer: ALARIS Medical Systems, Inc.
Problem: The ALARIS pump and the channel in use "burned out." The staff noted that one pump channel had malfunctioned, so the channel was changed out; however, there was no improvement. At this time, the staff noticed that the pump connections had shorted out and a burning odor was present. The pump was removed from service, and the medications were transferred to a new pump. There was no patient harm as a result of this malfunction.

Device: Pump, IV, Module PC Model# 8100
Manufacturer: ALARIS Medical Systems, Inc.
Problem: Mid-infusion, the pump channel malfunctioned. An insulin drip at the rate of 1.5 units/hour had been running through the channel for approximately 2 hours. The pump had two other channels set up and programmed, but they were not running. Approximately 30 minutes before the "CHANNEL ERROR" message was displayed, a phenylephrine drip had been started without problems. At the time of failure, no new channels were being started or added to the pump. The pump was plugged into the extension outlet, which was plugged into the wall. With the insulin infusion plugged in, and without warning or preceding errors codes, a message screen showing "CHANNEL ERROR" appeared, with additional text reading something to the effect that the pump needed to be taken out of service. No error code numbers were displayed (which were specifically looked for). Extension cords are used in the operating rooms, they are yellow in color and either a simple three-outlet strip or a larger, boxy-type contraption with a metallic face. No harm befell the patient, because the incident was readily detected, and the insulin was immediately switched over to a new pump.

Device: Pump, IV, Module PC Model# 8100
Manufacturer: ALARIS Medical Systems, Inc.
Problem: The failure of the ALARIS pump is described as follows: The call team was assembled for an emergent cardiac case for a patient in cardiac arrest with a presumed massive pulmonary embolism; the patient was coding when he/she arrived on the floor. The doctor programmed the ALARIS pump for the infusion of epinephrine and norepinephrine at high dosages. About 10 minutes later, the doctor happened to look at the ALARIS pump and found that it had shut down without any warning or audible alarm. There was a red light flashing on the front of the pump, but because every member of the call team was busy resuscitating the patient, no one saw it. It remains unclear how long the pump had not been infusing. In this incident, the problem was not due to a battery problem, because the machine was plugged in at the time.

Device: Pump, IV, Module PC Model# 8100
Manufacturer: ALARIS Medical Systems, Inc.
Problem: A secondary medication was to be programmed. The RN pressed the "Secondary Med" button. When the button was pressed, the entire pump shut down, flashed red, displayed "System Error," and then shut down the entire pump. All channels were needed, because this was an ICU patient with multiple medications running. All medications were reprogrammed onto a new pump.

Device: Pump, IV
Manufacturer: ALARIS Medical Systems, Inc.
Problem: The ALARIS pumps have a main pump unit (or CPU) which provides the infusion controls as well as the Guardrails software features. Attached to these are the various pump modules (standard IV or syringe pumps) that have the mechanical means to infuse medications. There is an edge connector with a number of pins that provides the electrical connection/communication interface between these two devices. We have encountered multiple device problems in which fluid intrudes this connection and creates a short, which then causes a variety of different failures, ranging from error codes, inappropriate or absent communication, burning odor, to smoking of the devices. The failures are dependant on the amount of fluid, the duration of time in which the fluid has infiltrated the connection, and the type of fluid that is present. ALARIS has not initiated any field notification regarding this specific issue, but the company has manufactured a new connector, which it is sending as a replacement part. The design of the connector appears to be the same and the old one, and we have a request in for more details on the specific change criteria to this in order to see if this is related to the fluid intrusion issue. Staff members are currently testing each device to ensure proper connectivity when a pump is received for repair, in addition to the annual scheduled preventative maintenance check. It should also be noted that we have started to install the latest Guardrails update today (Version 8), and we are testing the connection on each pump after the software upgrade is performed. A notice to staff from the nursing education team will be released regarding this issue, and an additional notification will be posted regarding checking the quality of the pump connections prior to use and keeping fluids away from the top of the case. Photographs of the connectors on some of the pumps have been taken to use as a visual representation in this message. I will follow up when I hear back from ALARIS regarding these continuing issues.


Device: Electrosurgical Unit, ForceTriad Energy Platform
Manufacturer: ValleyLab
Problem: We implemented these new electrosurgical units (ESU) within the last month and experienced three problems with the devices: 1. When using the bipolar device, the staff plugged in the double-pronged bipolar cord and noted that the connection receptacle and prongs would not stay connected (the fit was too loose). The Surgical Team had to discontinue use of the ESU device and delay the surgery in order to locate an older ESU unit for the procedure. 2. During an ectopic pregnancy case, staff used a needle laparoscopic electrode, which has a monopolar plug, and a "dummy" return electrode monitor (REM) plug. The device would not work during this emergency surgery, which caused a delay for the patient while the staff located another unit. We consulted with the vendor representative, and he said that the company was aware of the problem, because the newer ESU model required "true REM capability" in order to work. We were not informed of this issue when we purchased and implemented these devices. 3. On a third case, the plug for the bipolar Bovie fit snug in the connection, but the unit only worked intermittently when the bipolar was activated.

Device: Handpiece, ESU, Vessel Sealing Ligasure TYCO Ligasure V, 5 mm Sealer/Divider Model# LS1500 Lot# 1259100
Manufacturer: ValleyLab
Problem: During a laparoscopic nephrectomy procedure, a small wire was found protruding from the end of the Ligasure handpiece (Model# LS1500 Lot# 125910). The device was removed from the field. All lots were pulled from the core. This is the third occurrence involving four device malfunctions.

Device: Mesh, Surgical, PelviSoft Acellular Collagen BioMesh Lot# 06B15-9
Manufacturer: Bard Urological Division of C.R. Bard, Inc.
Problem: The patient had complications (abscess and inflammation) at the site of a previous surgery where mesh had been implanted. The abscess was cultured, and no growth resulted. The mesh was surgically removed 5 months later.

Device: Aortic Punch Lot# 70730-1 Other Device# MDP-52K
Manufacturer: Teleflex Medical
Problem: The patient was undergoing a coronary artery bypass graft (CABG) procedure. When the disposable aortic punch was positioned and fired to make a hole in the aorta for attachment of the graft, the device misfired. Instead of making a hole, it made a tear. The device was positioned in the same place and refired, and an adequate hole was made. The physician reported that since the original manufacturer of this device was bought out, the punches made by this device do not cut as cleanly as they should.

Device: Bed, Surgical, Quantum Surgical Table Model# 3080RL
Manufacturer: STERIS Corporation
Problem: The patient, undergoing a laparoscopic robotic-assisted prostatectomy, was positioned in steep Trendelenberg’s position on the STERIS Quantum Surgical Table. The surgeon reported that he could not move the robotic arms, and he noticed that the bed was spontaneously moving itself back to a level position. The robot was undocked from the patient and moved up, away from the patient. A regular laparoscope was inserted to assure no injury occurred and to reinsert trocars. No injury was noted. The procedure was completed. The patient was discharged to home in good condition on postoperative day 3. At the time the surgical bed moved, no one was near the bed controls. The bed moved on its own. The bed was removed from service after completion of the procedure. Fluid was found in the bottom of the table. The manufacturer found a leaking hydraulic tilt cylinder from deteriorated seals. The tilt cylinder was replaced and tested. Maintenance is scheduled twice yearly and had been performed less than 1 month prior to the event.


Device: Glucometer SureStep Flex Model# L6132SB00012
Manufacturer: LifeScan, Inc.
Problem: The glucometer read 32; when the sample was rechecked with another glucometer, the sample read 168. The patient was asymptomatic. The glucometer was sent to the laboratory that oversees the maintenance.

Device: Glucometer ACCU-CHEK Inform Model# 2001201
Manufacturer: Roche Diagnostics Corporation
Problem: The blood glucose result on ACCU-CHEK was 166, and the result from the laboratory was 259. Both tests were run on the same blood sample. ACCU-CHEK controls were completed, and no problems were identified.

Device: Urine Pregnancy Test Kit, Sure-Vue Lot# HCG7040077 Catalog# 23900530
Manufacturer: Fisher HealthCare
Problem: This is one of four instances in which patients had four false-positive pregnancy results when the urine pregnancy test kit was used. The serum pregnancy test was negative. The occurrence for these patients was over a course of a few days. As a result of the false-positive tests, all patients received sonograms. The manufacturer was contacted, and area hospitals were called to see if they were experiencing similar problems. The manufacturer sent a different lot to the facility; again, the urine pregnancy test kit gave four false-positive results for the same initial samples. The manufacturer then sent another lot that was received today. The test kit was retested on the initial sample, and it worked.


Device: Catheter, Ablation, Endometrial, NovaSure Impedance Controlled Ablation System Lot# NS2000
Manufacturer: Cytyc Surgical Services, Inc.
Problem: When the surgeon was using the device, the vacuum light came on three times, and ablation was incomplete. A new disposable device was opened, and the same thing happened. The surgeon was able to complete the surgery with another device. There was no patient injury. The Biomedical Department verified performance of the NovaSure device, and no problems were found. According to the service manual, the vacuum LED will illuminate when a blockage is detected in the disposable device or the connection tubing, or when the system has a leak. There are several situations in which this might be created: 1) an over-dilated cervix with poor contact between the cervical collar and the external OS; 2) a poor luer connection to the vacuum feedback or suction flush port; 3) a poor attachment of the desiccant tube to the suction tubing; 4) an obstruction in the disposable device tubing; 5) an obstruction in the disposable device. One week after the event, the ambulatory facility staff tried the device again in another procedure with the sales representative present, and there were no further problems. One month after event, no other problems have been reported. No followup is required. Scheduled preventive maintenance will continue on a semiannual basis.

Device: Catheter, Ablation, Endometrial, NovaSure Lot# 07E10H Catalog# 615202
Manufacturer: Cytyc Surgical Services, Inc.
Problem: Physician performed an endometrial ablation. On removal of the device, she noted that the gray tip of the device had melted and appeared sharp. The patient was examined for injury and none was found.


Device: Pad, Hyperthermia, Energy Transfer Pad Lot# 392105 Catalog# 00315-05Z
Manufacturer: Kimberly-Clark Corporation
Problem: Kimberly-Clark warming pads were being used on the patient during surgery. The side tapes on the pad were removed gently from the patient's sides. There was redness and weeping on both sides where the tape had been. Nursing was informed of the injury. Per the medical record, there were stage II skin tears to the chest laterally (axilla to hips).

Device: Attachment, Wheelchair, Traveler Model# B10320E
Manufacturer: Everest & Jennings
Problem: The hospital ordered 65 Everest & Jennings "Traveler-20" Wheelchairs from Graham Field. Along with the wheelchairs, we ordered the IV pole and oxygen tank holder combination attachment for the wheelchairs. The day after placing the wheelchairs with attachments into the hospital, a security guard verbally reported accidentally bumping into the IV pole attachment, which was set at eye height, and which poked him in the eyeglasses he was wearing. After reviewing the IV pole loops design, we realized that they poke out horizontally and could easily poke someone in the eye. Also, the attachment is designed to sit only at three different heights, all of which could be at one's eye level, depending on the person’s height.


Device: Software, Imaging e.soft v. 3.5
Manufacturer: Siemens Medical Solutions USA, Inc.
Problem: A radionuclide ventriculogram multiple-gated acquisition scan was performed in an imaging room with an EKG trigger set on negative polarity. The negative polarity caused the gated acquisition to start and end each image on the S-wave instead of the R-wave. The software could not correctly identify the end diastole (ED) frame to properly calculate the ejection fraction (EF). The EF results of several patients were 0–15 percent lower than a manually recalculated EF. The software should have been able to identify the ED frame by searching throughout all 32 frames of the acquisition. The current software only identifies the ED using the first 16 frames.

Device: Magnetic Resonance Imaging Achieva 1.5T
Manufacturer: Philips Medical Systems
Problem: The software key that would have enabled us to complete the appropriate scan on the patient expired. Philips Medical Systems had been notified 4 months prior to the event that one of the software keys on the system was going to expire on a specific date. The system does not identify what key is going to expire, so the technical staff did not know what systems were supported by the specific software key. Our facility had been assured by Philips that the update would be installed by them before the expiration date. Unfortunately, it was not, and the staff had no way of verifying which studies or types of sequences had been done. When Philips was notified of the event, the representatives claimed that they erroneously read the expiration date using European date convention rather than the U.S. date convention, so the month was read as the day and the day as the month.

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