BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CXE VOLUMETRICINFUSION PUMP

    MDR report key: 1971586 · Received January 27, 2011

    Report

    Report Number
    6000001-2011-00460
    Event Type
    Malfunction
    Date Received
    January 27, 2011
    Date of Event
    January 7, 2011
    Report Date
    January 7, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Removal / Correction Number
    6000001-12/1/08-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE DEVICE 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. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE CUSTOMER'S REPORTED CONDITION OF A COLLEAGUE INFUSION PUMP WITH A SMOKING, SPARKING AND BURNING AFTER REPLACING BATTERIES WAS CONFIRMED BUT COULD NOT BE DUPLICATED DURING PRODUCT EVALUATION. THE ROOT CAUSE OF THE BURNING, SMOKING, AND SPARKING COULD NOT BE DETERMINED. NO ACTIONS WERE TAKEN TO REPAIR THIS PUMP AS THIS IS A STAY-IN DEVICE. ADDITIONAL INFORMATION: THE SOFTWARE VERSION FOR THIS DEVICE IS COLLEAGUE P1.5 (6.13.92). SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH MDQ-CAPA (B)(4).

    Description of Event or Problem · 1

    THIS IS A REPORT FROM BAXTER (B)(4) OF A COLLEAGUE INFUSION PUMP THAT STARTED SMOKING, SPARKING AND BURNING AFTER REPLACING BATTERIES. IT IS UNKNOWN IN WHAT CARE AREA OR DURING WHAT PROCESS STEP THIS OCCURRED. THERE IS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE CXE VOLUMETRICINFUSION PUMP PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1