BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1051222 · Received May 23, 2008

    Report

    Report Number
    6000001-2008-00339
    Event Type
    Malfunction
    Date Received
    May 23, 2008
    Date of Event
    May 2, 2008
    Report Date
    May 13, 2008
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD
    Product Code
    FRN
    PMA / PMN Number
    K010566
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP IS IN THE PROCESS OF BEING EVALUATED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION, OF IF ANY ADD'L DETAILS BECOME AVAILABLE. THIS REPORT REPRESENTS ALL INFO KNOWN BY THE REPORTER AT THIS TIME.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A PUMP THAT ALARMED ON CHANNEL A WITH FAILURE CODE 810:11. THIS EVENT RESULTED IN AN UNINTENDED SHUT DOWN DURING PT USE. THE PUMP WAS SWAPPED OUT FOR ANOTHER. THERE WAS NO PT INJURY PER THE HOSPITAL REP. NO ADD'L INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP 80FRN FRN BAXTER HEALTHCARE PTE. LTD

    Patients

    Seq Age Sex Outcome Treatment
    1