BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CXE VOLUMETRICINFUSION PUMP

    MDR report key: 1831525 · Received September 10, 2010

    Report

    Report Number
    6000001-2010-03147
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    June 9, 2010
    Report Date
    July 7, 2010
    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

    (B)(4). DEVICE EVALUATION: THIS DEVICE WAS NOT RETURNED TO BAXTER FOR EVALUATION, HOWEVER DEVICE EVALUATION WAS PERFORMED ON SITE BY A BAXTER FIELD SERVICE ENGINEER. A VISUAL INSPECTION AND FUNCTIONAL TESTS WERE PERFORMED. DEVICE EVALUATION DISCOVERED AND CONFIRMED THE REPORTED CONDITION OF A BATTERY DEPLETED ALARM, AND DETERMINED THE ROOT CAUSE TO BE DEPLETED MAIN BATTERIES. THE MAIN BATTERIES AND BATTERY HARNESSES WERE REPLACED TO REPAIR THE REPORTED CONDITION. A FOLLOW UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4), A SERVICE HISTORY REVIEW REVEALED THAT THIS DEVICE HAS NOT BEEN PREVIOUSLY SERVICED FOR THE REPORTED CONDITION. 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 MDQ-CAPA-(B)(4).

    Description of Event or Problem · 1

    DURING A REVIEW OF THE PUMP'S EVENT HISTORY BY BAXTER (B)(4) PERSONNEL, A COLLEAGUE INFUSION PUMP WAS FOUND TO HAVE EXPERIENCED A DEPLETED BATTERY ALARM WHICH INTERRUPTED DELIVERY. THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. THE USER INTERFACE MODULE MASTER SOFTWARE VERSION IS 6.13.92, WHICH IS CLASSIFIED AS REMEDIATED. 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