BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1071532 · Received July 3, 2008

    Report

    Report Number
    6000001-2008-00412
    Event Type
    Malfunction
    Date Received
    July 3, 2008
    Date of Event
    June 16, 2008
    Report Date
    June 18, 2008
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED CONDITION OF A DEVICE THAT SHUTS DOWN BY ITSELF WHEN TURNED ON WAS CONFIRMED DURING PRODUCT EVAL. INSPECTION OF THIS PUMP REVEALED THE CONDITION WAS CAUSED BY DEPLETED MAIN BATTERIES. TO CORRECT THIS CONDITION, THE BATTERY HARNESS AND MAIN BATTERIES WERE REPLACED. THE PUMP WAS RETESTED, AND RETURNED TO THE CUSTOMER WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A PUMP THAT SHUTS DOWN BY ITSELF WHEN TURNED ON. THIS CONDITION OCCURRED BEFORE USE. THERE WAS NO PT INJURY OR MEDICAL INTERVENTION NECESSARY ACCORDING TO THE HOSPITAL REP. NO ADDITIONAL INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE CX VOLUMETRIC INFUSION PUMP 80FRN FRN BAXTER HEALTHCARE PTE. LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1