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U.S. Department of Health and Human Services

MedSun: Newsletter #90, December 2013

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Newsletter #90, December 2013

Articles

Philips Healthcare HeartStart Automated External Defibrillators (AED): Safety Communication

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FDA MedWatch Safety Alert

FDA issued a safety communication on HeartStart automated external defibrillators from Philips Healthcare. Affected devices may be unable to deliver needed defibrillator shock in a cardiac emergency situation. All owners of the Philips HeartStart AEDs should contact Philips Healthcare immediately at 1-800-263-3342, and select option 5 for technical support.

Additional Information:

HeartStart Automated External Defibrillators (AED) From Philips Healthcare: Safety Communication. FDA MedWatch Safety Alert. December 3, 2013.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm377446.htm

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Abbott FreeStyle and FreeStyle Lite Blood Glucose Test Strips: Recall

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FDA MedWatch Safety Alert

Abbott is initiating a voluntary recall of 20 lots of FreeStyle and FreeStyle Lite Blood Glucose Test Strips. These lots of test strips may produce erroneously low blood glucose results when used with both FreeStyle and FreeStyle Flash Blood Glucose Meters [neither of which have been in production since 2010], as well as the OmniPod Insulin Management System.

Additional Information:

FreeStyle and FreeStyle Lite Blood Glucose Test Strips by Abbott: Recall. FDA MedWatch Safety Alert. November 28, 2013.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm376984.htm

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Spacelabs Healthcare, Inc., Anesthesia Workstations and Service Kits: Class I Recall

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FDA MedWatch Safety Alert

FDA notified healthcare professionals of a Class I Recall due to a potential defect in the CAS I/II Absorber products employed in the BleaseSirius Anesthesia Workstation, BleaseFocus Anesthesia Workstation, and Service Kits Part Number 050-0659-00 and 050-0901-00. The Bag to-Vent switch in CAS I/II Absorbers may fail due to loose fastening hardware in an absorber.

Additional Information:

Spacelabs Healthcare, Inc., Spacelabs Anesthesia Workstations and Service Kits: Class I Recall. FDA MedWatch Safety Alert. November 26, 2013.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm376772.htm

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Hospira GemStar Infusion System: Class I Recall

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FDA MedWatch Safety Alert

The proximal and distal pressure sensor calibration can drift resulting in the pump failing the Proximal or Distal Occlusion Operational Test or resulting in an error being reported during device setup or infusion. A pump with this issue may, instead of reporting an error, not detect occlusions or issue false occlusion alarms, which will stop the infusion and invoke visual and audible warnings to the user. This issue may also result in the pump shutting down. Customers should immediately perform proximal and distal occlusion tests as defined in the GemStar Technical Service Manual.

Additional Information:

Hospira GemStar Infusion System: Class I Recall. FDA MedWatch Safety Alert. November 25, 2013.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm376723.htm

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Medtronic Guidewires: Recall

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FDA MedWatch Safety Alert

Medtronic, Inc. announced that FDA has classified the company's recently initiated voluntary field action related to certain guidewires. Based on an internal investigation following a limited number of complaints, Medtronic began notifying hospitals and distributors worldwide the week of Oct. 21 that some models of its guidewires from recent lots have the potential for the coating on their surface to delaminate and detach. Additional information about the recall, including the lot numbers of affected product, is accessible through the Medtronic website.

Additional Information:

Medtronic Guidewires: Recall. FDA MedWatch Safety Alert. November 19, 2013.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm375410.htm

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Highlighted MedSun Reports

Highlighted Reports

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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 November 2013. All other reports can be searched under the ‘MedSun reports’ menu pane.

Device:
Type: Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Manufacturer: Argon Medical Devices, Inc.
Brand: First Picc
Model#: 384232
Lot #: 11045325
Cat #: 384232
Other #: PICC 26 guage, 1.9 fr

Problem:
Came to bedside to begin care time. Infant crying vigorously, and arms and legs moving. Infant given pacifier and PICC line checked. Hub found in bed and had ? torn off portion in infant. Portion on infants arm still completely intact. Tegaderm intact. Hub in bed with some wetness of linen and small amount of blood loss with fluid. Dr. called to bedside immediately. When arrived, infants PICC line removed by same using adhesive remover and pacifier given to keep calm. Tolerated well. Removed intact per same. Measured 16.25 cm (portion removed). No harm to patient but needed to access another site for reinsertion of another PICC.


Device:
Type: Glucose Dehydrogenase, Glucose
Manufacturer: Roche Diagnostics Operations, Inc.
Brand: Accu-check Aviva

Problem:
An ambulance crew responded to a call and as part of the assessment of the patient, the paramedic learned the patient was diabetic (but not being treated for a diabetic issue). The paramedic reported that he/she opened the blood glucose monitor by taking off the green zip tie. Next, the paramedic put the test strip in the monitor and heard a long "beep" with a blank screen and the monitor would not turn on. The paramedic tried multiple times to turn on the monitor to no avail. The monitor only sounded with a long "beep." The paramedic removed the battery from the monitor and replaced it with a new battery and there was no change. There was not a back-up blood glucose monitor on the ambulance. The patient did not experience any ill effects or delayed care related to inability to check his/her blood glucose levels. In follow up, the monitor was taken out of service and plans were to send the meter back to the manufacturer.


Device:
Type: Instrument, Ultrasonic Surgical
Manufacturer: Ethicon Endo-Surgery, Inc.
Brand: Harmonic Ace Shears
Lot #: K91M45
Other #: PI1HKH07F

Problem:
Harmonic Ace HAR36 was opened for case. Once Harmonic was attached to cord and tested it was found that shaft would not rotate. The Harmonic was disassembled and reassembled with the same result. New Harmonic was opened. Case completed. No harm to patient.


Device:
Type: Set, Administration, Intravascular
Manufacturer: Care Fusion
Brand: Smart Site Infusion Set
Cat #: 2420-0500
Other #: Infusion Set for the Alaris model Medley pump

Problem:
When opening the package to use on an IV drip, the RN noticed that there was no roller clamp on the tubing.


Device:
Type: Stent, Superficial Femoral Artery
Manufacturer: Bard Peripheral Vascular Inc
Brand: Lifestent Solo
Model#: EX062003CL
Lot #: ANXC0074
Cat #: EX062003CL

Problem:
Percutaneous intervention of Right Superficial Femoral Artery of pt. Performed via Left Brachial and Right Dorsalis Pedis accesses. After retrograde access of involved leg (Right) and brachial access obtained, recanalization of chronic total occlusion of SFA was achieved through CTO techniques. 2 stents were successfully placed from Dorsalis Pedis access but size complement of on hand stents required 3rd stent to be placed from brachial access. With Life Stent deployment catheter positioned in appropriate area without incident under fluoroscopy, deployment was initiated. As standard deployment was underway by physician, the ratcheting mechanism of the deployment handle failed to continue operating and marker bands of stent were visualized in tightly contracted position proximal to the end of previously placed stent. Sales rep was called for guidance and reached via phone. Then per instruction, deployment handle was opened. Hypotube retraction wire was pulled to continue deploying stent. Retraction wire broke, leaving remainder of hypotube on the undeployed stent.Through manipulation of device under fluoroscopic guidance, catheter delivery system was able to be removed from body ensuring no trauma to surrounding tissues or vessels. Stent delivery tract flouroscopically examined to assure no embolized stent material. Stent struts were visualized as expanded and stretched to longer length than desired or appropriate for proper functioning of stent scaffolding. Entire deployment catheter was removed under fluoroscopy without incident. Trivial subintimal flow was visualized under fluoroscopy through stent structure. Proximal and distal vessels were visualized and found to be undamaged. Guide wires and sheaths were removed per standard procedure. Patient verbalized no discomfort and adequate pulse were assessed in RLE. Patient discharged to telemetry unit.


Device:
Type: Suture
Manufacturer: Ethicon, Inc.
Lot #: GE2108
Other #: H206VCP864D1

Problem:
There was an issue with the Ethicon 3-0 SH 18" vicryl plus CR/8 control release suture. These control release packages contain 8 separated sutures. Today, the #2 needle was noted already "released" from the suture material while still in the package, i.e. The needle had "popped-off" while still in package.


Device:
Type: System, Communication
Manufacturer: Curbell Medical Products, Inc.
Brand: Rauland Responder-5
Cat #: 2S16
Other #: Part number 41414U-101393A

Problem:
This facility has had multiple and regular instances were patients try to use the Nurse Call system and the nurse is unable to hear the patient. The patient activates the call light system, but the nurse is not notified. The staff are unable to hear the patient. We continue to send the hand held device back to the company. The company reports that a specific part within the call light is breaking (Part number 41414U-101393A). These are pillow speakers, typically used by patients who do not have use/control of their extremities or who are non-verbal. The call light is activated by the patient turning their head onto the device. Staff test the device when it is first installed in the patient room and the device appears to be working (the call light system activates). However, during the course of care, the call light breaks. There is no warning or signal that the device has broken. The call light system itself was installed in 2009.) There has not been patient harm; however, there is increased risk of patient harm because the nursing staff are not alerted to a patient's need when the call light system is not functioning. Facilities staff estimate that one device or more per month has been returned to the manufacturer. The manufacturer has not been able to provide a reason for the problem: the part is replaced and the device is returned to the facility.


Device:
Type: Monitor, Physiological, Patient
Manufacturer: Philips Medical
Brand: Mp30
Model#: MP30

Problem:
The monitor was reported to "lose power" and the display went blank. When inspected, the power cord was found to be detached from the back on the MP30 monitor, causing it to go into battery mode. After time on battery mode, the unit will eventually lose power and stop operating. The AC power indicator works but, it is not obvious when the power cord is unplugged and operating on battery power. A more visible indication of this is advised, as well as an audible tone when the battery becomes low, instead of simply shutting off the monitor. There appear to be two opportunities for improvement. Attaching the power cord to the device is not advised because that would introduce a new set of problems with the potential for monitor being pulled from mount and getting the power cord caught in a stretcher.


Device:
Type: Transmitters And Receivers
Manufacturer: Philips Healthcare
Brand: Telemetry Transmitter
Model#: M2601B

Problem:
A confused patient was being monitored using a Philips telemetry transporter device. Upon rounding on patient, the nurse noted that wireless device was off to the side lying on the bed and was very hot. The device was removed and inspected by bioengineering. One battery had "exploded" and a small plastic piece used to separate metal from metal had been dislodged. The patient was not harmed at all and the Philips service department was contacted by the Bioengineering Manager.

Per Philips Manufacturer's Service Dept. suspect the cleaning solution being used by the hospital (PDI Sani Cloth) is responsible for causing the plastic to weaken and break. Phillips to provide hospital with list of approved cleaning solutions.


Device:
Type: Pump, Infusion
Manufacturer: B.Braun Medical
Brand: Infusomat Space
Model#: 8713050U
Other #: Hospital BMI# 24455

Problem:
It was reported the patient was to be given Heparin IV at 7CC/hr (700U/HR) on continuous infusion for chest pain. Pump was programmed for 250 mL VTBI, which was the same as the supplied IV bag. Settings were confirmed by two nurses, and infusion was started.

Twenty minutes later, the pump alarmed for "infusion complete" and the IV bag was empty. The patient was given reversal agent for the over-infusion and admitted for continued observation. Patient was discharged several days later after monitoring.

Later review of the pump's electronic event log showed that the intended rate for the pump was 700 Units/hr, not 700 mL/hr as was programmed. The user programmed a simple rate/volume infusion and entered the right number, but the pump was not set to deliver Units/hr. Our Infusomat pumps have a drug library, but that was not selected. If it had been, the pump would have been sent to the right units or else it would have refused a setting of 700 mL/hr.

Performance tests on the pump gave results within acceptable limits, and the pump was then returned to clinical use.


Device:
Type: Shunt/valve, Cns
Manufacturer: Sophysa USA, Inc.
Brand: Polaris Vp
Model#: ID621211
Lot #: 172118/A0312
Cat #: 30-200

Problem:
Patient states she was seen in neurosurgery clinic for increasing headaches, decision made to dial shunt down to 70 from 110. Headaches persisted, so physician admitted patient to hospital for ICP bolt placement for further monitoring. After bolt placement, attending physician checked shunt pressure, which was still set at 110, so probably shunt was never dialed down in clinic to 70 as it should have been. Potential design problem with the ability to verify proper pressure after dialing down shunt.

Feedback received from the manufacturer was that there could be idiosyncrasies in the immediate post-operative period that could potentially make it challenging to adjust shunt appropriately.

The manufacturer does not recommend getting X-rays after a shunt reset to confirm the setting. We are beginning to think that early resets after surgery while there is still scalp swelling are difficult and should be confirmed with an X-ray (in spite of what the manufacturer says). This valve is new to the facility and has the advantage that it is not changed by MRI. However, we are finding that it is more difficult to adjust the setting.


Device:
Type: Unit, Phacofragmentation
Manufacturer: Alcon Research LTC
Brand: Accurus
Model#: 800CS

Problem:
While in the middle of a posterior vitrectomy of left eye, the Alcon Accurus vitrectomy machine stopped working and displayed error code 912-4. Checked all connections, attempted to reboot machine twice, exchanged cartridges in machine - all without success. Called sales rep and left message. Called Alcon tech support. Alcon tech support spoke with the hospital Biomed. After following instructions from tech support for a few things to try - without success - surgery was aborted, ports removed from eye, and incisions closed.


Device:
Type: Gamma Probe Drape
Manufacturer: Covidien, formerly US Surgical a divison of Tyco Healthcare
Brand: Navigator Gps
Cat #: PC3787

Problem:
After the patient left the OR, the C-Track probe was observed to have fresh blood on it. The only way blood could have gotten on the probe was if the disposable probe cover had a hole in it. The probe cover was retrieved from the trash and leak tested with water and was found to have 2 "pin prick" size holes in it.


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Updated December 1, 2013

Return to MedSun: Medical Product Safety Network

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