BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BPF 4 RED CELL LEUCOCYTE FILTER

    MDR report key: 220802 · Received April 23, 1999

    Report

    Report Number
    MW1016202
    Event Type
    Malfunction
    Date Received
    April 23, 1999
    Date of Event
    April 22, 1999
    Report Date
    April 23, 1999
    Manufacturer
    PALL BIOMEDICAL PRODUCTS, CO.
    Product Code
    CAK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FILTER HAD A LEAK IN STERILE AIR VENT, ALLOWING AIR TO GO INTO THE BAG ITSELF. LOST A UNIT OF BLOOD THAT HAD BEEN IRRADIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BPF 4 RED CELL LEUCOCYTE FILTER BLOOD FILTER CAK PALL BIOMEDICAL PRODUCTS, CO. * 833509

    Patients

    Seq Age Sex Outcome Treatment
    1 *