Highlighted Reports
MedSun: Newsletter #28, September 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 June 1 through June 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.


GASTROENTEROLOGY/UROLOGY

Device: Forceps, Grasper; ReNew Laparoscopic LapClinch Grasper Forcep Tip
Catalog #3251
Manufacturer: Microline Pentax, Inc.

Device: Handle, Laparoscopic;
Catalog #3904
Manufacturer: Microline Pentax, Inc.

Problem: Patient underwent laparoscopic cholecystectomy earlier this year. The patient tolerated the procedure well, but later developed jaundice. An ERCP was performed the following day to evaluate the patient for retained stones and/or bile duct trauma. The pancreatogram was normal; however, there was an incidental finding of a radiodense object that did not correspond to a known post-surgical object. This was disclosed to the patient. Two days after the original surgery a laparoscopic procedure was performed to remove the object, which was found to be a grasper tip from the initial surgery. The patient tolerated the procedure well. The device has two parts - a long handle and a threaded tip that screws on to the handle. The two parts were preassembled in the central processing. The members of this surgical team thought the instrument was only a one piece item; therefore the tip was not correctly included in the surgical count. If the tip is not firmly attached and/or be partially unscrewed during use it may fall off the handle. Now the two piece instrument is packaged unassembled in central processing, both pieces are included in the OR counts.

Device: Robotic Surgical System, da Vinci
Mode l#370761-04
Other Device # camera cable #5
Manufacturer: Intuitive Surgical, Inc.
Problem: In attempting to dock the Intuitive robot for a robotic-assisted laparoscopic prostatectomy, the patient cart would go forward a few inches, and then alarm and the screen would read "Fault." It was determined that the fault was due to either a short in the red cable between the cart and the console or by dust in the cable connections. All connections were cleaned and the robot worked without fault.

Device: Xenon Light Source
Model #X7000
Other #: Ref #220-190-000
Manufacturer: Stryker Endoscopy
Problem: Pt returned from the OR procedure, with a wound to the lateral aspect of the left hand. Reported to the bedside RN to be a burn from the OR equipment. Wound includes brownish/yellow areas to outside aspect of left hand and tips of two fingers. Doctor´s note lists wounds as second degree burns. Initially, we thought this was due to operator error, but subsequently there were 3 more reports of burns involving the same piece of equipment. The device was evaluated using a light meter, and found to be delivering about 12% higher light output than a different light source of the same model using the same lamp cartridge in both units. In addition, the heat output seemed to be much higher than the comparison unit, but we do not have proper test equipment to specifically measure heat output. It is possible the heat filter is not working properly, but no damage was visible. Excessive lamp current may be responsible for the dramatically increased heat output.


GENERAL AND PLASTIC SURGERY

Device: Electrode, ESU, Dispersive; REM Polyhesive II
Lot #136379
Other Device#: Ref#E7507
Manufacturer: Covidien ValleyLab

Device: Generator, Ablation, Cardiac; Stockert RF Generator
Manufacturer: Biosense Webster

Problem: Faint blush noted on patient’s left lateral side where pad was placed. There was a documented 2 inch linear red rash. The patient was then transported to PACU. The physician was notified and he ordered a wound care nurse consult and Silvadene creme. The patient was discharged in an improved condition with no delay in discharge. Discussion with reps from Biosense Webster and Valley Lab and risk manager: The red Valley Lab pads (REM Polyhesive II) are safer than the blue (Polyhesive) pads; however, these are the one causing the burns. It was discussed that quality of adherence or location/placement may be creating the problem. Also, monitoring of the ablation time should be 10 seconds on and 30 seconds off. Next steps: Use red pads and adhere properly and ensure correct location.

Device: ESU; Aquamantys 2.3 Bipolar Sealer
Manufacturer: Salient Surgical Technologies, Inc.

Device: Grounding Pad
Model# E7512
Manufacturer: Covidien (Valleylab)

Problem: Pediatric patient taken to surgery for liver mass. A bipolar electrosurgical device was used during the procedure. A grounding pad was placed on the left shoulder. After the procedure, it was discovered that the patient sustained two burns to the left shoulder area. The first burn was a 1.5cm.x1cm full thickness burn and located on the superior aspect of the left shoulder, slightly posterior. The second burn was also full thickness and measured 2cm x 3cm and was located on the upper back just lateral and inferior to the spine of the scapula.

Device: Cytoscopic Transurethral Injection Needle; Coaptite
Lot #100615
Other #: Ref #890-302
Manufacturer: Boston Scientific Corporation

Device: Cystoscopic Transurethral Injection Needle; Coaptite
Lot #1005143
Other #: Ref #890-302
Manufacturer: Boston Scientific Corporation

Problem: During transurethral Coaptite injection, needle became clogged and would not inject Coaptite. Different needle of same type/brand also was tried but also became clogged and would not inject Coaptite.

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Manufacturer response for cytoscopic transurethral injection needle, Rigid Injection Needle
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They have developed a new needle that works better.

CARDIOVASCULAR

Device: Catheter, Sheath, Introducer
Catalog #SI-09903-E
Other Device #AO-09000 (obturator)
Manufacturer: Teleflex Medical
Problem: This problem is actually ongoing. Once a cardiac patient no longer needs a pulmonary artery catheter, then it can be removed but the introducer is often left in place as an access site for fluids via the sideport. The access for the catheter, however, must be blocked off using an obturator. Nurses have repeatedly complained that it is more difficult now to put the obturator (aka blue cap) on the introducer's hemostasis valve resulting in patient discomfort and potential for minor injury. Comparison of current vs. earlier version of product with scanner: An older introducer (same product) was obtained from a nurse who specializes in training others about catheters, lines and access devices. The obturator easily goes onto this earlier version. Images of the hemostasis valves and o-rings were scanned and the difference in pixels between the o-rings' diameters translates to 0.005" with the current one being larger. This may be enough of a difference to account for the difficult obturator insertion.
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Manufacturer response for Percutaneous Sheath Introducer, Arrow Int'l
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The AO-09000 (the obturator) was measured and determined to be within specs by the manufacturer. It's the reporter's belief that the manufacturer did not attempt to fit it on recently manufactured hemostasis valves to see that is has become difficult to insert.

Device: Monitor, Multi-parameter module; CARESCAPE
Manufacturer: GE Medical Systems Information Technologies
Problem: During use in the OR, anesthesiologist observed "SpO2 module malfunction" when using GE PDM with Solar patient monitor. Changed out and re-seated SpO2 cables with no effect. GE responded by sending Engineering on-site to assess, evaluate situation and perform testing. Upon testing, GE worked with Masimo to determine root cause. Latched error message thought to be caused by fluid ingress in the Masimo cable (where contact is made) due to cleaning in the OR between cases. Biomed worked with Masimo to change out LNOP cable to LNCS cable which is less prone to fluid ingress issues. Will keep observing with new cables. GE issued an Internal Complaint in their tracking system to work on disable latching of probe/module malfunction message if a new cable is attached.

Note from FDA: Similar reports have been submitted with the Carescape monitor. To view these reports, visit the MedSun Reports simple search screen and enter Carescape in the 'Search For' text box.

Device: Patient Warming System; Hypo/hyperthermia Unit
Model# M1000
Manufacturer: Kimberly Clark
Problem: During a surgical procedure a patient received a small first degree burn on their back from a warming pad. The case was several hours and the temp was operating at 41 degrees. It was found during a root cause analysis (RCA) that there was a deviation from the standard usage of the warming pad with the use of a rolled towel causing the concentrated heat. The towel was rolled up and placed against the warming pad. The patient's weight, position of the patient (rolled on side to provide access during procedure) and the towel forced the warming pad tighter to the patient's skin causing a burn.

Device: Transmitter, Telemetry, Physiological; PatientNet Ambulatory Transceiver
Model #DT-4500
Other #: FCC ID: BQI01DT-4500
Manufacturer: GE Medical Systems Information Technologies
Problem: Patient was on a telemetry floor and was being monitored by an ambulatory transceiver. Patient heard a sudden loud noise and felt a slight vibration of the ambulatory transceiver. The central monitoring station noted a loss of signal from the transceiver, indicating a battery failure, so a nurse went to the patient to change the battery. While the nurse was changing the battery, (9V Duracell Procell product number 4F21 G305 17) the battery "popped" and the cardboard bottom came off the battery. The internal cylinders started to push out the bottom of the battery. The plastic cap on the end of some of the cylinders also popped off of the cylinder. The transceiver was taken out of service and the event reported to Biomedical Engineering. Engineering will be looking at the transceiver to see if there was a malfunction of the transceiver that caused the battery failure. Engineering believes that this is a battery problem, but felt a report should be completed in case other facilities are reporting this type of problem. The nursing staff found other batteries that popped. These were discarded/used batteries in the disposal bin and would pop in the bin. Duracell Global Marketing was notified of the battery failure and they removed all the batteries with lot #'s 4F15 and 4F21. The failed batteries will be returned to them so that they can look into the battery failure.

Device: Defibrillator, External, Biphasic; M series
Manufacturer: Zoll Medical Corporation
Problem: Failure to rescue a morbidly obese patient.
A morbidly obese patient with non-ST elevation myocardial infarction status post cardiac catheterization, placement of stent x2 when he had a cardiac arrest. Ten defibrillation attempts were made with the Zoll M Series biphasic defibrillator at 200 joules (the max) and hands free pads anterior / posterior placement. Unable to rescue patient. Another manufacturer's BIPHASIC device was obtained and the patient was shocked x1 with 360 joules which resulted in conversion to a perfusing rhythm. The Zoll M Series defibrillator was fully checked after this event and is working to specification. This is the second event we have seen of a failure to rescue a morbidly obese patient with a biphasic device at the maximum capacity 200 joules.


OBSTETRICS/GYNECOLOGY

Device: Vacuum Assist Device with Vacuum Cup, Fetal; Mytyvac, M Style, Mushroom
Catalog# 10007LP
Manufacturer: Cooper Surgical
Problem: After obtaining consent for a vacuum delivery, the mushroom cup Mityvac was placed and position was checked. Over the next two contractions, the physician did attempt to pull with the vacuum and there was one pop-off. The vacuum was not maintaining adequate suction beyond a level of 10-15. The vacuum was removed and a new replacement pump was obtained as well as the vacuum cup and tubing. The new vacuum was placed and again position was checked. Steady progress was made and the vacuum was maintained at approximately 45-50 in the green zone and there were no pop-offs. The cup and tubing was not retained and the lot number was not recorded. Early this year, a recall notice was received from Cooper Surgical regarding a recall of specific lot numbers of the disposable vacuum assisted delivery products. We did pull from inventory 12 items from one affected lot number.

Recall Online Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?ID=34888


ANESTHESIOLOGY

Device: Anesthesia Machine; Aisys Carestation
Serial# ANAL00353
Manufacturer: GE Medical Systems, LLC
Problem: A serious concern has been identified due to the lack of alarm on GE Medical Aisys Carestation anesthesia machine when inhalation agent is turned off by system and not by anesthesiologist. In this particular case, the anesthesiologist moved the machine backwards and inadvertently touched alternate O2 button on the machine. He realized it when he saw the message on the screen. When he turned the alternate O2 system off, the O2 flow came back to 2L, but the agent did not return to the original setting. This was missed until the patient was moved and sevoflurane was turned back on. Since ET sevo was still at 2, the 'agent off' did not draw his attention. GE was informed of the event, and has opened up an Internal Complaint in their tracking system on this particular issue.

Device: Ventilator
Manufacturer: Puritan Bennett
Problem: Physician and Respiratory Therapy were at the bedside making a ventilator setting change. Ventilator went in-operable and was not ventilating patient. The patient was removed from the equipment and staff started bagging the patient. The equipment was removed and replaced. Alarm screen went blank and the backup system did not kick in. There was no harm to the patient.

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Manufacturer response for Ventilator, Puritan Bennett 840 Ventilator
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Problem was caused by a defective GUI CPU. Vendor replaced GUI CPU. Performed Gas output and port hardware update and installed ferrites. Performed all required calibrations/verifications. Unit passed EST, PVT and electrical safety test.

Device: Analyzer, Arterial Blood Gas; ABL820 Flex
Serial #1902-754R0090N0005
Manufacturer: Radiometer America, Inc.
Problem: The patient was in the Emergency Department for altered mental status. Venous blood gases were run twice on this patient. The device was in the "green light" status. The first sample taken did not have a pH result, so a two point calibration was done and the sample was run again, the results were pH: 6.819, pCO2: 58.1, pO2: 59.2, cHCO3: 6.5, cBase: -26.1. The results were reported to the physician as critical, but per the physician, this was not consistent with the patient's clinical presentation. An hour later, a second sample was obtained and run with device in "green light" status and no pH value was given. A second two point calibration was done, the sample was run again with results of pH: 6.659, pCO2: 47.8, pO2: 41.6, cHCO3: 4.1, cBase: -31.6. These results were reported to the physician as critical, and again this did not match the patient's clinical presentation. Bicarb was considered, but was not given. An ABG was drawn and run on a different machine and the results were within normal limits. There was no patient harm. Coincidentally, the machine's power supply blew and the machine became inoperable. After the power supply was replaced and the machine tested, it was determined that there was a dried blood clot in the analyzer. This was removed and the machine functioned properly. The facility is currently assessing a new syringe that will mix samples better to prevent clotting.

Device: Anesthetic Gas Module; IntelliVue
Model #M1019A
Manufacturer: Philips Healthcare
Problem: This has been an ongoing concern in our OR's and has been affecting multiple machines. 12 Phillips G5 IntelliVue Anesthetic Gas Modules were introduced to our OR's earlier this year. We immediately started having issues with the G5's "locking up." It happens in all stages during the case and even after the case when the patient has been disconnected and out of the room. It has even happened in empty rooms. The G5 LED's will be flashing and the patient monitor is on "standby". Phillips decided to replace the original 12 machines with 12 new ones thinking perhaps we had received a bad batch. The problems have continued - Phillips has even sent techs from Germany and Andover on two separate occasions to troubleshoot the issues, as well as having Radio Frequency (RF) and Power experts to look at possible environmental concerns. All of their testing shows no obvious reason for this to be happening. Our Biomed Tech has described the problem as: The Phillips monitor displays all question marks where the information from the G5 should be displayed. The anesthesiologists don't have any c02, in02, inN20, etN20 readings. They lose the gas identification and all of the other necessary information. The G5 has two LED's on the front (set up and standby). When we experience this problem the standby LED is lit solid and the setup one flashes and is not responsive to anything but a power cycle. From having the Phillips techs onsite we have discovered the G5 loses communication with the monitor and if the data cable is removed from the patient monitor for 10-15 seconds and then plugged back in the data will re-populate again. This is faster than the power cycle so when these problems occur the doctors and anesthesiologist techs have just been removing this cable and reattaching to get the data back. This problem does not affect any other information on the patient monitor such as ECG, SP02, NIBP. It is just the information from the G5 gas analyzer.

Phillips has indicated they feel the issue is environmental but it is so sporadic and intermittent it is difficult to determine what exactly could be causing problems.

Device: Kit, ETCO2; Aquat-knot II Kit
Manufacturer: GE Medical Systems, LLC
Problem: The manufacturer has issued a rolling back order and the product is temporarily out of stock with no safety back up. The product is necessary for ETCO2 monitoring in the ICU and intraoperatively.


NEUROLOGY

Device: Clamp, Surgical, Head Support; Mayfield Skull Clamp
Model #A1059
Manufacturer: Integra LifeSciences Corporation
Problem: Surgeon placed skull clamp on patient's head. Patient then turned prone in preparation for surgery on cervical spine. Clamp was firmly attached to Mayfield base support which is firmly attached to the OR table. While head was being repositioned by surgeon the swivel lock appeared to become unlocked and patient's head fell downward with the bridge of his nose striking the crossbar of the skull clamp. This injury was superficial. The surgeon once again repositioned and re-secured the head but then the head was "spontaneously ejected" from the skull clamp, resulting in a deep 5cm laceration above the right ear. This required closure with skin staples.

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Manufacturer response for Skull clamp/head support, Mayfield
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The manufacturer acknowledged the device's inherent instability. They supplied us with a loaner clamp while they evaluate ours. They provided me with the instructions for use at my request. The IFU does state that "The direction of the single pin should point directly through the center point created by the centerlines of the patient's head with the pins on the two-pin side of the skull clamp being equidistant to single-pin line of direction to obtain the highest degree of stability."

Recall Online Available at:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?ID=33840

Device: Generator, Lesion; Radionics
Manufacturer: Covidien Valleylab
Problem: Burn to left scapula area discovered after the trigeminal nerve ablation surgery. Burn is size of a dime, full thickness requiring Silvadene cream and follow-up in Burn Clinic.
Impedance all over, changed the cable. Took off the grounding pad and didn't notice anything.
The impedance was found to vary significantly during this lesion (up to 4000 ohms), but it returned to normal (around 300 ohms) following the lesion.


RADIOLOGY

Device: Transformer, Low ImpedancePower Conditioner
Model #4450028-01 50/60 HZ 3 Phase
Manufacturer: TEAL Electronics

Device: Scanner, CT; VISION MX 8000
Model #728201
Manufacturer: Philips Medical Systems

Problem: The isolation transformer caught fire in the Phillips CT scanner, while the scanner was sitting idle. The emergency response alert was initiated and the fire was extinguished. The damage was all contained inside the transformer cabinet. There was some smoke released into the surrounding air, but no harm to staff or patients.

Recall Online Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?ID=64322


ORTHOPEDIC

Device: Plate, Orthopedic; DVR-Distal Volar Radius Plate
Model# DVRA-A STANDARD LEFT PRODUCT; DVRA-L
Manufacturer: Hand Innovations, LLC
Problem: Patient was admitted to the hospital for repair of a fractured left wrist. The operation required the use of a plate with seven (7) screws to stabilize the fracture. Each screw has a guide device used to direct the screw into the bone. After the screw is inserted into the bone, the guide is removed. It was determined that this particular style of orthopedic device was not frequently used by our staff and was designed to have separate fast guides whereas other similar devices were designed with all of the fast guides connected together so that they were removed as a set rather than individually. Consequently, this device requires a separate count for each screw guide while the more frequently used device removes all of the screw guides at once. The OR staff was not aware of this counting requirement with this device. A post-operative X-ray was taken to verify the placement of the plate. The X-ray revealed the presence of one of the screw guides. The patient was return to the OR and the guide was removed without complication.

Note from FDA: Please see recent article describing issues seen in this report, posted in August 2008's Newsletter online available: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/news/newsletter.cfm?news=27#5


OPTHALMIC

Device: Glaucoma Valve Flexible Plate; Ahmed Glaucoma Valve Flexible Plate
Model #FP7
Lot #B0308
Manufacturer: New World Medical Inc
Problem: Patient returned to OR 8 days after initial surgery due to collapsed anterior chamber of the left eye. The tube on the device was noted to have a laceration upon inspection after removal. Manipulation of the tube on inspection led to splitting of the tube.


GENERAL HOSPITAL

Device: Pump, IV, CPU; Medley
Model #8015
Manufacturer: Alaris Medical Systems, Inc.

Device: Pump, IV, Module; Medley
Model# 8100
Manufacturer: Alaris Medical Systems, Inc.

Device: pump, IV, module; Medley
Model# 8100
Manufacturer: Alaris Medical Systems, Inc.

Problem: Patient receiving TPN at 80 ml/hr. Infusion stopped at 0430 to draw labs. Nurse restarted infusion and thought that rate was set at 80 ml/hr with approximately 2000 ml still in bag. Approximately 2 hours later, pump alarming and TPN bag empty. Pump taken out of service. When event/error log downloaded revealed that rate had been set at 880 ml/hr. Concern that there may be keypad bounce that is not immediately evident to user. Pt developed a-fib and was transferred to ICU had no long term harm.

Device: Pump, PCA/chemo; GemStar
Manufacturer: Hospira Global Medical Affairs
Problem: Patient had received a home infusion pump with 5FU infusing. Two days later the patient arrived as per appointment for discontinuation of medication and pump. Infusion was set to run for 46 hours.

On arrival, patient stated that the infusion pump had alarmed approximately 30 minutes prior to arrival. The patient stated that after the pump alarmed she took out the batteries. Patient stated that the pump screen read "bag empty" before she removed the batteries. She stated that she noticed that the bag was not empty.

Upon assessment of the pump, the screen was blank and pump was off. The batteries were not inside the pump. The patient gave me the batteries. I reinserted the batteries and turned the pump on. I checked the pump history. Screen indicated volume infused: 133ml. Settings were: Volume - 138 ml, Rate: 3ml/hr, as per MD order. Air alarm ON. Contents of IV bag were drawn up, and 55 cc of chemo agent remained in the bag, representing 16 hours of medications that had not infused. Various factors were reviewed and none could explain the remaining volume. Pharmacy loads the bag and has a triple check mechanism in place using three different people to verify the contents, rate and volume. The machine was not yet due for a re-calibration (required every 6 months).

We believe there is a faulty mechanism that does not deliver the intended volume despite remaining fluid in the bag. In this case, the machine was set and verified at 138 ml for total volume to be infused. However, the machine only delivered 83 ml. This may not seem like much - but over the course of 12 chemo treatments - close to 16 hours or more of chemo will not be infused. We are reviewing all chemo patients for the past several months, looking at what the Gemstar delivered versus what was ordered.


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