BEUDAMED
    FDA Adverse Event Death Summary report: N

    LEUKOFILTER

    MDR report key: 218479 · Received April 10, 1999

    Report

    Report Number
    218479
    Event Type
    Death
    Date Received
    April 10, 1999
    Date of Event
    March 24, 1999
    Report Date
    April 5, 1999
    Manufacturer
    BAXTER HEALTHCARE CORP FENWAL DIVISION
    Product Code
    CAK
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT DEVELOPED TRANSFUSION REACTION DURING ADMINISTRATION OF PACKED RED BLOOD CELLS USING A LEUKOPORE FILTOC. PT EXPIRED SEVERAL DAYS LATER ON 3/27/99. MEDICAL EXAMINER REPORT PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEUKOFILTER BLOOD TRANSFUSION FILTER CAK BAXTER HEALTHCARE CORP FENWAL DIVISION NA A98L09083 OR A98L07095

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Death