BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL

    MDR report key: 1964393 · Received January 19, 2011

    Report

    Report Number
    6000001-2011-00349
    Event Type
    Malfunction
    Date Received
    January 19, 2011
    Date of Event
    October 27, 2010
    Report Date
    November 2, 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
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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). DEVICE EVALUATION: THIS DEVICE WAS EVALUATED ONSITE AT THE FACILITY BY A BAXTER TECHNICIAN. A VISUAL INSPECTION AND FUNCTIONAL TESTS WERE PERFORMED. DEVICE EVALUATION CONFIRMED THE REPORTED CONDITION OF A PUMP FAILURE AS A BATTERY DEPLETED ALARM. THE ROOT CAUSE WAS DETERMINED TO BE DEPLETED MAIN BATTERIES. THE BAXTER REPAIR TECHNICIAN REPLACED THE MAIN BATTERIES AND HARNESS TO RESOLVE THIS ISSUE. A FOLLOW UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT A COLLEAGUE INFUSION PUMP EXPERIENCED A BATTERY ISSUE. BAXTER'S REVIEW OF THE DEVICE EVENT HISTORY DETERMINED A BATTERY DEPLETED ALARM CAUSED AN INTERRUPTION OF DELIVERY. THE USER INTERFACE MODULE MASTER SOFTWARE VERSION IS 6.63.90, WHICH IS CLASSIFIED AS REMEDIATED. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    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