BEUDAMED
    FDA Adverse Event Other Summary report: N

    (COBE) R/LS SYSTEM-HEMASURE

    MDR report key: 305314 · Received November 18, 2000

    Report

    Report Number
    305314
    Event Type
    Other
    Date Received
    November 18, 2000
    Date of Event
    October 27, 2000
    Report Date
    November 17, 2000
    Manufacturer
    (COBE) GAMBRO BCT
    Product Code
    CAK
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SEVERE TRANSFUSION REACTION TO AS-1 RED BLOOD CELLS, LEUKOCYTES REDUCED. TRANSFUSION STARTED - 2:00 P.M, STOPPED - 2:05 P.M., DUE TO SEVERE LOWER BACK PAIN, BP FROM 108/60 THEN 170/88, PULSE 72 THEN 88 (25CC TRANSFUSED). THREE DAYS LATER SECOND SEVERE TRANSFUSION REACTION TO AS-1 RED BLOOD CELLS, LEUKOCYTES REDUCED. TRANSFUSION STARTED - 2:15 P.M, STOPPED AT 2:25 P.M, DUE TO LOWER BACK PAIN, TEMP. 98.1 THEN 99.3 (40 TRANSFUSED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 (COBE) R/LS SYSTEM-HEMASURE PRESTORAGE LEUKOREDUCTION FILTER CAK (COBE) GAMBRO BCT R/LS M0098D

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other