Highlighted Reports
MedSun: Newsletter #31, December 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 September 1 through September 30. All other reports can be searched under the ‘MedSun reports’ menu pane. Note: the two month delay is due to quality control and follow-up.


ANESTHESIOLOGY

Device: Carts, Medication
Manufacturer: Armstrong Medical LTD
Problem:
A nurse discovered our crash carts really do not lock. The newer version we have only has one metal tab thus allowing yellow plastic lock to slide through slot allowing drawers to be opened. I have pictures to show older models and new models.

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Manufacturer response for Crash Carts, Pediatric ALS Color-Coded Cart and Adult Carts
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They do not seem to understand the problem and I have sent pictures but rep cannot come until next week. We discovered this last week. We are concerned this may be a widespread problem with this cart and people may not be aware that cart really is not locked when it seems to be locked.

Please see crash cart lock images.
New adult crash cart showing how lock can slide through slot resulting in cart not being locked. New pediatric crash cart showing how lock can slide through slot resulting in cart not being locked. New pediatric crash cart showing how lock can slide through slot resulting in cart not being locked. Old model crash cart showing superior locking design.  Lock unable to slide throguh the slot.


CARDIOVASCULAR

Device: Lead, Lvad
Model# Heartmate II
Manufacturer: Thoratec Corporation
Problem:
In the postoperative period, the patient was noted to have intermittent pump stoppage consistent with a cracked percutaneous lead. The percutaneous lead underwent a radiography and demonstrated a potential crack along its distal portion. The patient was taken emergently to the operating room for replacement of the HeartMate II left ventricular assist device.

Please see recall on this device online available at http://www.fda.gov/oc/po/firmrecalls/thoratec10_08.html

Device: Monitor, Physiological
Model# Dash 4000
Manufacturer: GE Medical Systems Information Technologies
Problem:
Monitors would beep then screen would go blank, a few seconds later screen would come back but data would be changed and clock time is off. This happened with several monitors so it affected several babies.


GASTROENTEROLOGY &UROLOGY

Device: Control Valve, Ro
Model# 2850
Manufacturer: Pentair - Home of Fleck
Problem:
In our Dialysis unit we have 4 Fleck heads mounted on tanks for a multimedia filter, a water softener, and 2 carbon tanks that treat our incoming water before it enters the RO system. During a three week period, three of the pistons inside of the Fleck heads broke off of the piston shaft and became stuck; all three were pushed in fully when the break occured. This interrupted dialysis when the piston for the carbon tank broke, and patients were diverted to another facility until replacement parts were obtained and installed.

Device: Reprocessing Machine, Endoscopy
Manufacturer: Olympus America Inc.
Problem:
One of the automatic endoscopic reprocessing (AER) machines was found to have a broken connector tube, which is used to flush the high-level disinfectant through the inside channel of the scope during reprocessing. Endoscopic reprocessing includes an initial manual cleaning with an enzymatic detergent, brushing inside channels and exterior surfaces and thorough rinsing. The automated process includes leak testing, submersion and flushing all lumens with high-level disinfectant for several minutes (per manufacturer's recommendation), rinsing all surfaces, with a final alcohol flushing of lumens and forced air sent through the channels to facilitate drying. This particular connector tube was found coiled in one of the AER reprocessing chambers after the last day's run cycle. When it was straightened the tube was found severed in half at the base. It is unknown if the break during the straightening of the tube or if it had been broken during previous run cycles, thus potentially preventing adequate high-level disinfection of the (inner lumens) of scopes reprecessed in that particular machine.

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Manufacturer response for Disinfector, Olympus DSD
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Olympus contacted to determine if the machine would automatically abort a run if there was a break in the connector tube. Olympus said it would not abort, it would abort only if the tubing is completely occluded or if the leak test fails.

Device: Tubing, Insufflation
Model# 620-040-690
Manufacturer: Stryker Endoscopy
Problem:
Tip broken off tubing where it connects to laparoscopic trocar.

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Manufacturer response for insufflation tubing, PneumoSure insufflation tubing
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The rep verbally reported that the company has been aware of the problem with the glue in this tubing for several months. They are apparently working on a solution, but no adequate replacement will become available for several more weeks and they continue to provide tubing with known breakage issues.


GENERAL HOSPITAL

Device: Infant Abduction System
Model# PRO-ROAM-UMB
Manufacturer: Prosec Protection Systems Inc.
Problem:
Nurse discovered bleeding from umbilical cord. This is the third incident in which the cord clamp has failed.

In reviewing these incidents, we have hypothesized that the transponder for the infant security system may have contributed to the failure of the clamp. The transponder is placed in the ring at one end of the clamp. The transponder is held very tightly by clamps from this manufacturer. (Nursing staff does not recall having similar problems with our previous clamp manufacturer.)

After reporting these incidents to the clamp manufacturer, we have been informed that their device is not compatible with the transponder system. Also, according to the maker's of the transponder system, the only clamp that is designed to be used with the system is their own proprietary clamp.

Device: Prep Solution With Applicator, Chloraprep
Manufacturer: Cardinal Health
Problem:
RN was prepping patient with Chloraprep sponge for IV insertion. Patient's skin was scratched, causing some bleeding, from something sharp coming through the sponge.

Device: Pump, Implantable
Manufacturer: Medtronic Inc. (Neurological)
Problem:
To determine whether the pump was working properly, biomed performed testing using dye. Testing revealed that the dye never reached the catheter. We have had this issue with other pumps, as well as catheter patency issues. The patient will be started on oral baclofen and then the family will be given the choice between explant or replacement.

Device: Pump, Infusion
Model# Prizm
Manufacturer: Smiths Medical
Problem:
The patient was connected to a TPN infusion during the evening, and the following morning no reduction in solution volume within the bag was noted. The pump produced no alarm and the patient indicated that the pump sounded like it was working during the intended infusion.

Device: Pump, Intrathecal
Model# 8637-40
Manufacturer: Medtronic Neurological
Problem:
Patient with intrathecal pump. Outside medication provider unable to refill pump. Patient to neurosurgery clinic. Unable to refill pump. Patient to OR for replacement of pump and new medication. Pump was found to be plugged. Medication from outside company noted to be cloudy.

Device: Syringe, Pre-filled, Heparin
Model# 10units/ml 3ml in 12ml syringe
Manufacturer: Amsino Medical USA
Problem:
RN went to heparinize a patient's central line after IV push medication. RN obtained a pre-packaged heparin flush syringe, attached to the central line and attempted to push in heparin and met resistance in the line. RN d/cd the syringe from the line to discover that the syringe was empty - syringe did not have heparin, but only air.


OBSTETRICS/GYNECOLOGY

Device: Umbilical Cord Clamp
Manufacturer: Owens & Minor, Inc.
Problem:
Nurse discovered bleeding from umbilical cord. This is the third incident in which the cord clamp has failed.

In reviewing these incidents, we have hypothesized that the transponder for the infant security system may have contributed to the failure of the clamp. The transponder is placed in the ring at one end of the clamp. The transponder is held very tightly by clamps from this manufacturer. (Nursing staff does not recall having similar problems with our previous clamp manufacturer.)

After reporting these incidents to the clamp manufacturer, we have been informed that their device is not compatible with the transponder system. Also, according to the maker's of the transponder system, the only clamp that is designed to be used with the system is their own proprietary clamp.


RADIOLOGY

Device: X-ray Machine, Portable, Digital

Model# 5151481-3
Manufacturer: GE Medical Systems, LLC
Problem:
The X-ray machine malfunctioned when tech was attempting to take an X-ray on a patient. The machine did not beep when the X-ray was being taken. While techs were assessing the problem, the patient's mother stated that there was smoke. It was coming from the digital detector that was near the patient. When the technician picked up the detector by the handle, she touched the cable which was very hot. Device was removed from service.

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Manufacturer response for X-ray machine, portable, digital
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GE replaced both the cable that got hot as well as the power supply. GE contends that a circuit breaker within the power supply should have prevented this type of event. Power Supply was sent to GE headquarters for further evaluation.


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