BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMUFLEX DISPOSABLES

    MDR report key: 3232559 · Received July 18, 2013

    Report

    Report Number
    1722028-2013-01284
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 19, 2013
    Manufacturer
    TERUMO CORPORATION/TERUMO BCT
    Product Code
    CAK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) INVESTIGATION: THE SET WAS NOT RETURNED FOR INVESTIGATION. RESERVE SAMPLES FOR THIS LOT WERE VISUALLY EXAMINED, AND THE SOLUTION VOLUME AND SOLUTION COMPOSITION WERE TESTED, WITH NO ABNORMALITIES NOTED. THE MANUFACTURING AND TESTING RECORDS WERE REVIEWED. THE LOT CONFORMED TO ALL SPECIFICATIONS. THE PRETREATMENT PROCESS OF CATIONIZATION HAD BEEN SWITCHED TO ANOTHER MACHINE, AFFECTING THIS LOT. ROOT CAUSE: A DEFINITIVE ROOT CAUSE FOR THIS FAILURE COULD NOT BE DETERMINED. THE FOLLOWING POSSIBLE ROOT CAUSES ARE: THE PRETREATMENT PROCESS FOR CATIONIZATION WAS MOVED TO ANOTHER MACHINE. HEMOLYSIS CAN ALSO BE CAUSED BY THE FOLLOWING:-CHARACTERISTICS OF BLOOD, E.G. RED BLOOD CELL FRAGILITY-BACTERIAL CONTAMINATION-EXCESSIVE COOLING-FILTER CLOGGING - FILTRATION TIME IS EXTENDED BECAUSE THE FILTER IS LIKELY TO CLOG, AND WHEN RED BLOOD CELLS FLOW THROUGH SUCH A FILTER, A PHYSICAL STRESS ON THE RED BLOOD CELLS MAY CAUSE HEMOLYSIS. CORRECTIVE ACTION: THE PRETREATMENT PROCESS OF CATIONIZATION HAS BEEN MOVED BACK TO THE ORIGINAL MACHINE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A UNIT OF HEMOLYZED PLASMA FROM WHOLE BLOOD. THERE WAS NOT A TRANSFUSION RECIPIENT OR PATIENT INVOLVED AT THE TIME OF THE WHOLE BLOOD PROCESSING FOR PLASMA UNITS, THEREFORE NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT. THE DISPOSABLE SET IS UNAVAILABLE FRO RETURN BECAUSE THE CUSTOMER DISCARDED IT. THIS REPORT IS BEING FILED DUE TO A DEVICE MALFUNCTION THAT HAS THE POTENTIAL FOR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334312 IMUFLEX DISPOSABLES IMUFLEX WB-RP BLOOD BAG SYSTEM CAK TERUMO CORPORATION/TERUMO BCT 130422KK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other