BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CXE VOLUMETRIC INFUSION PUMP

    MDR report key: 1051217 · Received May 23, 2008

    Report

    Report Number
    6000001-2008-00342
    Event Type
    Malfunction
    Date Received
    May 23, 2008
    Date of Event
    May 1, 2008
    Report Date
    May 16, 2008
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE PUMP BE RECEIVED FOR EVAL, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVAL OR IF ANY ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A PUMP WITH A DAMAGED BATTERY ALARM. THIS CONDITION OCCURRED DURING A PT INFUSION. THE INFUSION WAS STOPPED BY THE DAMAGED BATTERY ALARM ON THE PUMP AND WAS SWITCHED OUT TO ANOTHER PUMP WITH NO INJURY TO THE PT OR MEDICAL INTERVENTION NECESSARY ACCORDING TO THE HOSPITAL REP. NO ADD'L INFO IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1