BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL

    MDR report key: 1686128 · Received May 13, 2010

    Report

    Report Number
    6000001-2010-00552
    Event Type
    Malfunction
    Date Received
    May 13, 2010
    Date of Event
    May 9, 2010
    Report Date
    May 10, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Removal / Correction Number
    6000001-12/1/08-002C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).EVALUATION SUMMARY: THE REPORTED CONDITION OF A COLLEAGUE INFUSION PUMP WHICH EXPERIENCED SMOKE COMING FROM THE REAR OF THE DEVICE WAS CONFIRMED DURING PRODUCT EVALUATION. THIS CONDITION WAS CAUSED BY A BATTERY HARNESS ELECTRICAL SHORT WHICH BURNED THE USER INTERFACE MODULE PRINTED CIRCUIT BOARD. THE USER INTERFACE MODULE PRINTED CIRCUIT BOARD AND BATTERY HARNESS WERE REPLACED TO CORRECT THE REPORTED CONDITION.

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE PUMP BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4). A SERVICE HISTORY REVIEW REVELED THAT THIS DEVICE WAS NOT PREVIOUSLY SERVICED FOR THE REPORTED CONDITION OF 'BURNING SMELL'. (B)(4).

    Additional Manufacturer Narrative · 1

    THIS DEVICE UTILIZES USER INTERFACE MODULE MASTER SOFTWARE VERSION 5.09.90 CATEGORIZED AS REMEDIATED. (B)(4).

    Description of Event or Problem · 1

    THE FACILITY REPORTED A COLLEAGUE INFUSION PUMP WHICH, UPON BEING PLUGGED INTO AN ELECTRICAL WALL OUTLET, EXPERIENCED SMOKE COMING FROM THE REAR OF THE DEVICE ACCOMPANIED BY AN ELECTRICAL BURNING SMELL. THIS EVENT OCCURRED IN THE FACILITY'S MEDICAL/SURGICAL CARE AREA WHILE AN INITIATION OF A PATIENT INFUSION WAS BEING ATTEMPTED. THE PUMP WAS SWAPPED OUT AND THE INFUSION RESUMED ON ANOTHER DEVICE. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THE USER INTERFACE MODULE SOFTWARE VERSION FOR THIS PUMP IS CURRENTLY UNKNOWN.

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF SEIZURE IN A (B)(6) MALE PT WHO RECEIVED SUPER POLIGRIP ULTRA FRESH DENTURE ADHESIVE CREAM ((B)(4)) FOR DENTURE ADHESION. A PHYSICIAN OR OTHER HEALTHCARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON AN UNK DATE, THE PT STARTED SUPER POLIGRIP ULTRA FRESH (DENTAL). IN 2006, THE PT EXPERIENCED SEIZURE, DIZZINESS, VOMITING, ABDOMINAL DISTRESS, ZINC INCREASED, COPPER LOW, PARESTHESIA OF THE ARM, ARM PARALYSIS, EXPIRED DRUG USED, UNABLE TO GET UP, DIFFICULTY STANDING AND BURSITIS. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. TREATMENT WITH SUPER POLIGRIP ULTRA FRESH WAS DISCONTINUED. AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENTS WAS UNK. CONSUMER REPORTED THAT HE BEGAN USE OF SUPER POLIGRIP APPROX 15 YEARS AGO. HE USED ANOTHER DENTURE ADHESIVE PRIOR TO THAT TIME. BEGINNING IN 2006, HE HAD SEIZURES 2-3 TIMES PER WEEK, DIZZINESS, VOMITING, ABDOMINAL DISTRESS, PARASTHESIA AND PARALYSIS OF HIS LEFT ARM. IN 2008, HE WAS TESTED AND FOUND TO HAVE HIGH ZINC AND LOW COPPER LEVELS. HE REPORTED THAT HE HAD AN EPISODE WHERE HE COULD NOT GET UP DUE TO DIZZINESS, HE WAS TAKEN TO AN EMERGENCY ROOM BUT REFUSED TO BE ADMITTED. HE STOPPED USE OF SUPER POLIGRIP LATE IN 2008 AND WITHIN 6 HOURS, ALL OF HIS SYMPTOMS RESOLVED. HE REPORTED THAT A DOCTOR TOLD HIM THAT PARASTHESIA AND PARALYSIS OF HIS LEFT ARM WAS DUE TO BURSITIS. HE REPORTED THAT HE WAS TESTED FOR ZINC AND COPPER LEVELS ON (B)(6) 2010 AND DOES NOT YET HAVE THE RESULTS. HE REPORTED THAT HIS LAST TUBE OF SUPER POLIGRIP HAS THE LOT CODE R04373B (EXPIRED 2007) AND HE STOPPED USE OF SUPER POLIGRIP IN 2008. SUPER POLIGRIP ULTRA FRESH IS MFG IN (B)(4). WHILE THE LOT NUMBER FOR THIS PRODUCT IS KNOWN (R04373B, EXPIRATION 2007), IT IS UNK IF THE PRODUCT WILL BE RETURNED FOR QUALITY ASSURANCE TESTING. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD INTERMITTENT STIMULATION AND "NEVER HAVING THERAPEUTIC EFFECT" FOLLOWING IMPLANTATION. ADD'L INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1