BEUDAMED
    FDA Adverse Event Death Summary report: N

    COLLEAGUE VOLUMETRIC INFUSION PUMP

    MDR report key: 1231367 · Received November 17, 2008

    Report

    Report Number
    6000001-2007-88291
    Event Type
    Death
    Date Received
    November 17, 2008
    Date of Event
    April 24, 2007
    Report Date
    May 24, 2007
    Manufacturer
    BAXTER HEALTHCARE PTE.LTD
    Product Code
    FRN
    PMA / PMN Number
    K010566
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. THE FACILITY REPORTS THAT THE PUMP HAS BEEN SEQUESTERED. THE FACILITY HAS REFUSED TO RETURN THE PUMP BECAUSE REPORTEDLY THIS ISSUE IS IN LITIGATION AND THE PUMP MAY NEVER BE RELEASED TO BAXTER. AN ON-SITE VISIT WAS OFFERED TO THE FACILITY BUT THE FACILITY HAS DECLINED A VISIT AT THIS TIME. SHOULD THE PUMP BE RECEIVED FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILLED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A PATIENT RECEIVED AN OVER INFUSION OF MILRINONE WAS IN A 100ML BAG. THE PUMP RATE WAS SET FOR 126ML/HOUR. THE PATIENT REPORTEDLY RECEIVED 82.9ML IN APPROXIMATELY 40 MINUTES. THE PATIENT EXPIRED SHORTLY THEREAFTER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death