Highlighted Reports
MedSun: Newsletter #22, March 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 December 1 through December 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.


Device: Bag, Rebreathing, Anesthesia, Adult Circle Breathing Circuit
Lot# 290D
Catalog# Axxxx114
Manufacturer: Vital Signs, Inc.
Problem: Ongoing problems with Vital Signs adult circle breathing circuit (aka anesthesia bags). Previously, bags were too stiff; our anesthesiologists had given feedback to company rep. Over past 3 weeks, bags are breaking during use - daily - popping while in use along seams. The failure can occur at any time. Sometimes the break occurs during the anesthesia machine check, sometimes during hand ventilation. This failure happens with many lots, however lot 290D seems to be the worst. We have taken this lot off of our inventory.


Device: Syringe, IV, Contrast, Stellant
Model# 3007301
Lot# 70432
Manufacturer: Medrad, Inc.
Problem: The patient underwent a CT scan with IV contrast of the abdomen and pelvis. Air was injected into the patient's vein instead of the contrast, though some contrast may have been injected as well. Air was identified in the right ventricle and pulmonary outflow tracts. The rubber seal within the plastic chamber of the Medrad Stellant injector was found to have "cuts" in the rubber on some of the other injectors in the same lot. Cuts in the seal would result in an incomplete seal, and cause contrast to leak out onto the floor and air to be introduced.

Device: Paging System, Alarm
Model# GX520
Manufacturer: Emergin Inc.
Problem: The nurse was unable to assign her patient to a remote notification pager. Attempts were made to use another pager, telemetry transmitter, CIC (Central Information Center), as well as the back up Emergin paging server. After extensive troubleshooting, it was determined the problem was related to the spelling of the patient's name. Letters in the patient's name were interpreted as a command mode. The problem was duplicated on other Philip's CICs, CDS (clinical data servers) and Emergin paging servers. All of the CDS had database version D.01.01-05 and software version D.01.01-04. The Emergin paging server was running software version 7.02. The problem was duplicated on Emergin paging servers with software version 7.00 and 6.0. The Philips CDS was running software version E.00.28. The problem was also duplicated on CIC's with software version G.00.18 and E.01.15. The mfr worked with the facility on this problem. The mfr installed a patch (software fix) at the facility. The Biomed Director could not say if the software fix was only done at their facility, or if the fix would be done at other facilities that use this device.

Device: Ablation System, Cardiac, HIFU UltraCinch
Other Device# REF# UC-11
Manufacturer: St. Jude Medical, Inc.
Problem: Epicor pulmonary vein ablation device was placed without difficulty circumferentially around the pulmonary veins, and the process of delivery of the high frequency ultrasound gave excellent pressures and temperatures. As we came to the final round of the most superficial ablation layer, a large amount of blood was noted welling up in the pericardium. We immediately stopped the ablation, removed the device, and saw that the whole left atrial suture line had unraveled, likely as a result of the energy delivered by the adjacent device. We immediately reinitiated extracorporeal circulation for 20 minutes and were able to repair the suture line of the left atrial closure.

We then noticed that there was an additional site that was still bleeding. Went back in for an additional 12 minutes and were able (while the heart continued to beat) to repair this as well. The patient was then taken off bypass, but immediately failed with marked distention, which seemed to be worse on the right side of the heart.

Attempts to place an intra-aortic balloon pump at the groin were unsuccessful; however one was successfully placed in the ascending aortic arch. Ultimately, patient was able to come off of the heart lung machine for a short time, but the heart had no intrinsic contractility. Despite multiple resuscitative efforts, the patient expired in the OR.
Manufacturer response for deployable tissue ablation device, UltraCinch
Rep. was present in the OR at the time of the event. He was contacted again on the day of event.

Device: Monitor, Physiological
Model# M8004A
Catalog# MP50
Manufacturer: Philips Medical Systems
Problem: Philips Intellivue patient monitors, Models MP50 and MP70, have been experiencing an error message called “MMS Unplugged”, meaning that the monitor has lost communication with the Multi-Measurement Server (MMS). When this error occurs, a blue light at the top of the monitor flashes, a dinging alarm sounds, and the words “MMS Unplugged” appear at the top of the screen. After a variable amount of time, the error stops and the MMS automatically reconnects to the monitor, but the issue will recur after interval amounts of time. During the time of the error message, the patient is not being monitored by the vital signs devices connected to the MMS. On the MP70 monitors, the error message appears in a loop pattern every 40 seconds until a user turns off the monitor and resets it, at which point the error message no longer appears until a possible later date. This has occurred on several of our MP70 monitors. One of many issues we are concerned about is if the patient has an invasive aortic BP line, and re-setting the monitor will cause the monitor to loose its calibration. The other major concern is that Philips has not provided a permanent fix to the “MMS Unplugged” issue.

We have not seen this error message appear on any MP50 monitor at our facility until last month, when this message appeared on a monitor on the pediatric unit. In this instance, the error code does not follow the same predictable 40 second loop that the MP70 monitor does. The error code appears at random intervals of time, ranging from seconds, to minutes, to hours. Also, the error does not go away after the MP50 is turned off and then reset on this particular monitor. The Biomed has been unable to fix the monitor thus far, and has taken it out of service.

We believe this to be a patient safety issue because the patient is not monitored during the time of the error message. Additionally, the central monitor and nurse call phone system fail to notify the nurse that the patient is no longer monitored. Even if the nurse does happen to walk by the patient’s room at the time of the error code, he or she would not be able to fix or reset the monitor.
Manufacturer response for Intellivue Patient Monitor, Philips
Philips does not have any idea why the monitor is behaving this way. The field service rep has taken the monitor to be examined by Philips’ engineers.


Device: Broncho-scope
Model# EB-270S
Manufacturer: Fujinon, Inc.
Problem: Epidemiology/Infection Control Department became aware of a cluster of Pseudomonas aeruginosa (Pa) isolates with a unique antibiogram pattern recovered from patients who had undergone bronchoscopy with a BAL (BRONCHOALVEOLAR LAVAGE). The investigation determined that the source was a bronchoscope, which was found to culture positive for Pa despite a negative leak test and high level disinfection. Based on these findings, the bronchoscope was removed from service and the outbreak or pseudo-outbreak was terminated. The manufacturer's exam of the bronchoscope showed internal defects. Epidemiology performed molecular typing studies on available Pa patient isolates and on the Pa isolates recovered from the bronchoscope. Molecular typing studies using pulsed-field gel electrophoresis showed that all Pa isolates with the particular antibiogram pattern were identical, which confirmed the hypothesis that the bronchoscope was the reservoir for P aeruginosa. Medical records of the 12 patients who underwent bronchoscopy and had a positive Pa had no evidence of an infection due to this organism, and that the positive culture appeared to be due to BAL cultures collected through the contaminated bronchoscope (with the exception of the index case who was thought to have a Pa pneumonia at the time of bronchoscopy). Of the cluster cases studied, two patients may have had an adverse outcome associated with the exposure to the contaminated scope. Both patients died, however, these 2 patients were not expected to survive their current hospital stay due to other existing co-morbid conditions.


Device: Kit, Peritoneal Dialysis, Dialy-Nate
Lot# 1071129
Manufacturer: Utah Medical Products, Inc.
Problem: Neonate had Dialy-Nate peritoneal dialysis (PD) drainage system in place and was receiving 5 ml flush passes every 2 hours. It was noted, about 20 minutes after a flush pass that the Dialy-Nate set had come disconnected at the point where the outflow tube from the patient connects to the collection meter. The tubing had slipped out of the amber yellow connector. The system was turned off to the patient and a new system, including PD solution was replaced. When the MD was informed, he stated this was the third incident he was aware of in a 2 month period.

Device: Monitor, Esophageal, pH, Bravo
Lot# Q205724
Manufacturer: Medtronic, Inc.
Problem: The physician used the Bravo pH delivery system to place the Bravo pH capsule in the esophagus. It appeared that the capsule had been successfully placed; however, when the scope was used for further internal examination, the Bravo capsule was found unattached, laying in the esophagus. The physician removed the capsule and placed another without difficulty. However, because a second capsule needed to be used, the patient had approximately 30 extra minutes of conscious sedation. Both the capsule and the delivery system appeared to be in working order. There were no visible defects and there were no indications when the probe was placed that it was not functioning properly. The delivery system plunger was functional and suction was applied for 30 seconds before the plunger was depressed, as per the manufacturer's instructions. The surgeon and staff are experienced in using this equipment & have not had this happen before. Of note, another physician had the same experience with this equipment--staff noted that the capsules from both of these procedures came from the same lot.
Manufacturer response for pH capsule, Bravo pH capsule
The manufacturer was contacted. We are currently awaiting mailing instructions to return the device to them for inspection and analysis.

(Note from FDA: An adverse event report describing a similar problem and the same device lot number has been received.)


Device: Catheter, IV
Lot# 1859855
Manufacturer: Cook, Inc.
Problem: This report is to notify the FDA of labeling changes by Cook on their 7 Fr Tri-Lumen catheters, which we believe is introducing the possibility of a human error as the original color coding is being changed between the distal and proximal connections of the catheter.

Device: Sterilizer, Hydrogen peroxide Sterrad
Model# 100S
Manufacturer: Advanced Steriliza-tion Products
Problem: Employee was removing items from the sterilizer when noted something sticky on her hands, which then started to burn. She did a cool water rinse for >15 minutes, but still had a few minor burn areas on her fingers.

Device: Tubing, IV, LifeShield
Model# 20795-48
Lot# 57039 5H
Manufacturer: Hospira Global Medical Affairs
Problem: Staff finding difficulties with roller clamp. It either allows the IV bag to flow freely or it stops suddenly. When the RN set the rate with the roller clamp and later returned to find that patient has received the whole bad of IV fluid. This patient received 1000ml of normal saline bolus. The desired rate of fluid flow was estimated at 100ml/hr. Patient doesn't have any medical history that would concern us with the patient getting the extra liter of fluid in a very short time. Patient was examined before discharge and found no fluid overload or any other complications.
Manufacturer response for Primary IV Set, LifeShield
Sales Rep took possession of the product on the day of the incident and provided tracking number for manufacturer evaluation.

Device: Cabinet, Medication, Dispensing, Acu-Dose
Manufacturer: McKesson Automation, Inc.
Problem: The Acu-Dose froze up during the night. Called nursing supervisor to get key from ER to open door on Acu-Dose. No key was found in ER. Called pharmacy at other facility and they reported to me to call the 1-800 number for McKesson. I called McKesson and explained the situation. The rep told me to open the side door and I explained to him that we could not locate the key to open door. He told me to try the control-alt-delete function. I tried this and no change in computer status. He then told me to unplug the unit. He said the downfall of this is we take a chance for the computer not to come back on. When I re-plugged in the Acu-Dose the computer did not come on. I then informed the supervisor that she needed to contact a pharmacist so we could locate a key. She called pharmacy and they contacted the pharmacist to come in. He did try to reset the Acu-Dose after he opened the door and nothing happened. He then called McKesson with the cabinet number and he explained what he had done. McKesson sent someone to replace the computer on IMC Acu-Dose. Nurses on this night had to visit other nursing units to obtain any medicine for their patients that were due. It took approx 4 hours of down time.

Device: Drainage Set, Pleural/Pneumo-pericardial, Fuhrman Pleural and Pneumo-pericardial Drainage Set
Lot# 1467034
Catalog# C-PPD-850
Manufacturer: Cook, Inc.
Problem: This was a patient on ECMO, HFOV and Nitric Oxide who was a post-diaphragmatic hernia repair. The catheter was used as a chest tube for drainage. The tip sheared off and this resulted in a tension pneumothorax which required an additional chest tube placement. We are pretty sure that the catheters are all from the same lot (those from previous incidents). In previous incidents, the problem (staff states that there were visible tears in the catheters) was noted prior to use on the patient.

Device: Needle, Hypodermic, Needle-Pro Needle
Lot# 1085046
Manufacturer: Portex, Inc. A Division of Smiths Medical
Problem: When using Smith, Portex Hypodermic Needle-Pro with Needle Protection, 25 gauge x 5/8, lot #1085046 expiration 2011-11, staff reports that when giving an IM injection of viscous fluid, a pop is heard inside the needle and the plastic portion is breaking off with the needle still in the patient. Examples include refrigerated flu, Hep A and Hep B vaccination. The "popping" sound is heard when the medication flows through the plastic connector to the needle. This has happened six times out of the current box.
Manufacturer response for Hypodermic needle pro with needle protection, 25 guage X 5/8, Portex
They consider it user error. They claim that we are not "seating" the needle. They have not provided any additional training or in-services for the use of this device.

Device: Tubing, IV
Lot# 1180835
Catalog# FB1L03
Manufacturer: Smiths Medical
Problem: IV tubing malfunctioning causing tubing to pull away from cassette. 2 separate lot numbers affected at the same time, while priming IV tubing.
Manufacturer response for IV Tubing, Standard IV Tubing Universal Straight Sets
The manufacturer assigned a reference number. Requested material back for evaluation, stated new lot numbers were not manufactured with undersized tubing as was found in the previous 5 lot numbers reported.

Device: Pump, Syringe Medfusion 3500
Manufacturer: Smiths Medical
Problem: The syringe pump delivered a dose of Fentanyl at a rate that was five times faster than intended. This particular device contains a defective syringe size mechanism has been redesigned once before, and the one that we had fail is from the most current released version. The defective syringe size detection mechanism caused the pump to recognize the 5ml syringe as a 1ml syringe, which resulted in an infusion five times faster than intended. Specifically, there is a small shaft the goes through the middle of a spring. There is a small lip around one end of the shaft, and one end of the spring rests against this lip. When the mechanism failed, a portion of the spring slipped over the lip of the shaft and caused the syringe size detection clamp to not close 100%, which resulted in the size detection error. The only way to detect there is a problem is to push down on the size detection clamp, as you can see there is a small air gap and that it does not come all the way down and touch the case. Smiths Medical is currently working on another change to the current design to prevent this error from occurring again in the future.


Device: Instrument, Robotic, da Vinci
Catalog# 400183
Manufacturer: Intuitive Surgical, Inc.
Problem: A small piece of plastic was found inside the patient during a robotic laparoscopic procedure. The physician went back in to determine if any additional pieces could be found. No additional pieces were found. It was determined that the piece of plastic that was initially found was from the Permanent Cautery Hook. It appears to be similar to a washer that surrounded a pin at the end of the cautery.
Manufacturer response for Permanent Cautery Hook 8 MM, Da Vinci
Please send it back to the factory so we can evaluate it.

Device: Micro-discectomy System, SpineJet System and Resector Handpiece
Model# 55500
Manufacturer: Hydro-Cision Inc.
Problem: Intraoperatively, at the time of device set up for the patient procedure, the manufacturer representative noted that the Hydrocision handpiece inflow line had kinked near the console connection area when the Hydrocision footswitch was activated. When the rep. tried to unkink the inflow line near the console, the tubing wall broke and injected high pressure saline into the thumb of the rep. The rep. reported extreme pain and discomfort, saying that it felt like a "hammer smashing his thumb". When a second handpiece and inflow line was attached to the console, the tubing exhibited the same kinking behavior when the foot switch was activated. The managing OR nurse noted that there was no warning or caution in the instructions on the use of the handpiece, or instructions on what to do when the inflow line kinks. The RN also noted that the reps thumb was still numb on the tip one week after the event during a follow up conversation.
Manufacturer response for hydrosurgical system, SpineJet System and Resector handpiece
The manufacturer representative was the user injured by the device. He took the handpiece and broken inflow tube assembly with him to send back to manufacturer for analysis.

Device: Breast Implant Sizer, Gel, Resterilizable, Round, High Profile
Lot# 5724732
Catalog# RSZ-6004
Other Device# 107415-017 and EART107415-001A
Manufacturer: Mentor Corporation
Problem: Patient scheduled for capsulectomy with breast implant exchange. Dr requested Mentor re-sterilizable sizer to be used which apparently is a new product on the market and first time seen by surgery center staff. The mentor gel implants were stacked on the cart with the re-sterilizable sizer. I opened the re-sterilizable sizer to field and it was placed in 50,000 units of bacitracin in 1000 cc 0.9 NS for washing. Dr then started placing sizer in patient when she asked about another item from the box. I then picked up the box to check and noticed the small triangle which stated "non sterile". Dr. immediately informed and sizer was removed from field. Entire surgical field set up changed. Patient re-prepped and ancef 1 Gm. IVPB given. Wound irrigated with fresh Bacitracin 50,000 units in 1000 0.9 NS. I do not remember, nor does Dr. remember seeing a red label stating "non sterile" that was on the top of the other unopened reusable sizer. Three nurses who were called in the room to assist went through the bag of trash and no red "non sterile" sticker was found. Outer box and outer plastic wrap was found, minus red warning sticker. The sizer inner package opened just like all other sterile implants do as we have been using all along.


Device: Glucometer MediSense Precision Xtra
Model# 130-001-05 C1
Manufacturer: Abbott Laboratories
Problem: EMS experienced an error with a Precision Extra glucometer device. The ambulance crew had responded to a call at another facility for a patient with an altered level of consciousness. On their arrival the facility staff reported an initial blood glucose reading in the 40s. This facility staff had administered oral glucose and IM glucagon prior to the ambulance arriving, with a recheck blood glucose reading in the 50s. The ambulance crew checked the patient’s blood glucose level twice with their device and received readings of 208 and 192 respectively. The patient was transported to the hospital ED and remained unresponsive. After the call was completed it was reported to the EMS supervisor that this patient’s labs showed a blood glucose level of 20 (per the hospital lab). The patient was admitted to the ICU for observation and discharged the next day. The glucometer was immediately pulled from service, and returned to the manufacturer.

Device #1: Battery, Glucose Meter, Easy Pack
Model# 3.7 V 2000 mHh
Lot# 66380 712 099 Meter, Glucose
Device #2Stat Strip
Model# 42224
Lot# 00001L07143
Manufacturer #1: VARTA Micro-battery, Inc.
Manufacturer #2: Nova Biomedica
Problem: This event occurred while replacing a battery in the glucose meter. While a charged battery was being placed into meter, the battery started to smoke and popped out of the meter. The battery then turned black and continued smoldering and smoking. Upon investigation, the battery was found to have burned a hole in the counter. There was no patient harm as a result, but the employee reported being bothered by the smoke from the burning battery. However, upon evaluation, no injury was identified. All batteries from this same manufacturer with the same date were removed and replaced. The manufacturer requested return of battery, meter, and docking station for analysis, and is currently pending investigation.

Device: Analyzer, Diagnostic Clinitek Status Analyzer
Model# 132387
Manufacturer: Siemens Medical Solutions Diagnostics Sub Siemens Medical Solutions USA
Problem: Device produced five false positive hCG pregnancy test results from patient urine samples, resulting in the retesting of nine other patients.


Device: Tray, Circumcision,
Model# DYNFD 1044
Lot# 07EB1724
Manufacturer: Medline Industries, Inc.
Problem: Disposable Circumcision Kit contained four pieces which were assembled to do the procedure. During the procedure, the round knob was turned to tighten the bell piece. According to the physician performing the procedure, "the bell piece never felt as if it had a tight seal." The clamp was tightened to the maximum and the bell piece remained loose. The loose seal provided inadequate tension, which resulted in heavy bleeding at the site. Suturing and hemostatic agent were required.

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