BEUDAMED
    FDA Adverse Event Death Summary report: N

    LEUKOTRAP WB, VENTED, 450ML, CP2D/AS3 WITH SDP-HQ

    MDR report key: 1296404 · Received January 22, 2009

    Report

    Report Number
    MW5009758
    Event Type
    Death
    Date Received
    January 22, 2009
    Date of Event
    November 14, 2008
    Report Date
    January 7, 2009
    Product Code
    GKT
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS A MALE WITH ANEMIA, CHRONIC HEART FAILURE AND CHRONIC OBSTRUCTIVE LUNG DISEASE. HE WAS TRANSFUSED IN 2008, WITH A UNIT OF BLOOD DRAWN ONE MONTH PRIOR, USING PRODUCT 726-92Q (LOT 0800708). THE TRANSFUSION WAS STOPPED AFTER APPROXIMATELY 1/4 OF THE UNIT WAS INFUSED BECAUSE THE PATIENT EXHIBITED CHILLS, DYSPNEA, HYPOTENSION AND TACHYCARDIA. THE PATIENT WAS TRANSFERRED TO AGGRESSIVE CARE AND DIED SHORTLY THEREAFTER. THIS EVENT OCCURRED IN HOSPITAL IN ANOTHER COUNTRY..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEUKOTRAP WB, VENTED, 450ML, CP2D/AS3 WITH SDP-HQ NONE GKT 0800708

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death