BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFURBED COLLEAGUE CX TRIPLE CCHANNEL VOLUMETRIC INFUSION PU

    MDR report key: 1712086 · Received June 7, 2010

    Report

    Report Number
    6000001-2010-00645
    Event Type
    Malfunction
    Date Received
    June 7, 2010
    Date of Event
    May 25, 2010
    Report Date
    May 25, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: SERVICE HISTORY REVIEW DETERMINED THAT THIS DEVICE HAS NOT BEEN PREVIOUSLY SENT INTO SERVICE FOR THE REPORTED CONDITION OF 'INTERMITTENT STOP KEY ON THE CHANNEL C PUMPHEAD MODULE KEYPAD.' A DEVICE HISTORY REVIEW WAS PERFORMED AND FOUND NO EXCEPTION WAS OBSERVED DURING MANUFACTURING. 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).

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY:THE CONDITION OF A COLLEAGUE INFUSION PUMP WITH AN INTERMITTENT STOP KEY ON THE CHANNEL C PUMPHEAD MODULE (PHM) KEYPAD WAS FOUND AND CONFIRMED BY A BAXTER SERVICE TECHNICIAN. NO ASSIGNABLE CAUSE WAS PROVIDED DURING PRODUCT EVALUATION. HOWEVER, THE CHANNEL C PHM KEYPAD WAS REPLACED TO CORRECT THIS CONDITION.

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER (HUSBAND OF PT) AND DESCRIBED THE OCCURRENCE OF JOINT PAIN IN A FEMALE PT WHO REC'D SUPER POLIGRIP (FORMULATION UNK) FOR DENTURE ADHESION. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON AN UNK DATE, THE PT STARTED SUPER POLIGRIP. AT AN UNK TIME AFTER STARTING SUPER POLIGRIP, THE PT EXPERIENCED JOINT PAIN, RHEUMATOID ARTHRITIS, JOINT DISORDER AND ARTHRITIS. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. AT THE TIME OF REPORTING, THE EVENTS WERE UNRESOLVED. NO CONTACT INFO WAS PROVIDED SO THIS CASE IS LOST TO F/U. SUPER POLIGRIP IS MANUFACTURED IN (B)(4), AND NEITHER THE PRODUCT NOR LOT NUMBER FOR THIS PRODUCT IS AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    DURING PRODUCT EVALUATION BY A BAXTER SERVICE TECHNICIAN, A COLLEAGUE INFUSION PUMP WAS FOUND TO HAVE AN INTERMITTENT STOP KEY ON THE CHANNEL C PUMPHEAD MODULE KEYPAD. THERE WAS NO PATIENT INVOLVEMENT; THEREFORE, NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION IS ASSOCIATED WITH THE REPORTED CONDITION. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS DEVICE IS AN UNREMEDIATED COLLEAGUE PUMP WITH A USER INTERFACE MODULE SOFTWARE VERSION OF 5.04.00.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REFURBED COLLEAGUE CX TRIPLE CCHANNEL VOLUMETRIC INFUSION PU PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1