BEUDAMED
    FDA Adverse Event Other Summary report: N

    PALL PXL8 LEUKOCYTE REDUCTION FILTER FOR PLATELET TRANSFUSIO

    MDR report key: 120927 · Received September 19, 1997

    Report

    Report Number
    2432733-1997-00043
    Event Type
    Other
    Date Received
    September 19, 1997
    Date of Event
    August 19, 1997
    Report Date
    August 22, 1997
    Manufacturer
    PALL BIOMEDICAL PRODUCTS CO.
    Product Code
    CAK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    A PT BEING TRANSFUSED THROUGH THE DEVICE EXPERIENCED HYPOTENSION, DYSPNEA AND INDISTINCT CONSCIOUSNESS AFTER RECEIVING A FEW DROPS OF PLATELET CONCENTRATE (PC).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALL PXL8 LEUKOCYTE REDUCTION FILTER FOR PLATELET TRANSFUSIO LEUKOCYTE REDUCTION FILTER FOR PLATELET TRANSFUSION CAK PALL BIOMEDICAL PRODUCTS CO. PXL8V2 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention