BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUAD BLOOD PACK 500ML WITH FLEXEXCEL RED CELL

    MDR report key: 2994340 · Received March 1, 2013

    Report

    Report Number
    MW5029249
    Event Type
    Malfunction
    Date Received
    March 1, 2013
    Date of Event
    March 18, 2012
    Report Date
    March 1, 2013
    Manufacturer
    FENWAL
    Product Code
    KSR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AK, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING FILTRATION, COMPONENT TECH NOTICED TWO BAGS HAD FAULTY ONE-WAY VALVE THAT ALLOWED RED BLOOD CELLS TO BYPASS THE WHITE BLOOD CELL FILTER AND FLOW DIRECTLY INTO THE CONTAINER LABELED AS LEUKOCYTE REDUCED RED BLOOD CELLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89469 QUAD BLOOD PACK 500ML WITH FLEXEXCEL RED CELL NONE KSR FENWAL FM11L05028

    Patients

    Seq Age Sex Outcome Treatment
    1