BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMUFLEX DISPOSBLES

    MDR report key: 2962365 · Received February 14, 2013

    Report

    Report Number
    1722028-2013-00937
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    December 13, 2012
    Report Date
    January 17, 2013
    Manufacturer
    TERUMO BCT
    Product Code
    KSR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION: THE DISPOSABLE SETS WERE RECEIVED FOR EVALUATION. THE SETS WERE VISUALLY INSPECTED. NO ABNORMALITIES WERE NOTED. SAMPLES WERE TAKEN FROM THE SETS AND TESTED FOR HEMOLYSIS. HEMOLYSIS WAS CONFIRMED. HEMOLYSIS TESTING WAS PERFORMED ON THE CATIONIZATION AND SUPER-CATIONIZATION MEMBRANES, WITH HEMOLYSIS FOUND. RESERVE SAMPLES FOR THIS LOT WERE VISUALLY EXAMINED, AND THE SOLUTION VOLUME AND SOLUTION COMPOSITION WERE TESTED, WITH NO ABNORMALITIES NOTED. THE MANUFACTURING RECORDS WERE REVIEWED WITH NO ISSUES NOTED. ROOT CAUSE: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. IT IS POSSIBLE THAT THE CATIONIZATION LEVELS OF THE FILTERS IS CAUSING THE HEMOLYSIS. HEMOLYSIS CAN ALSO BE CAUSED BY THE FOLLOWING: -CHARACTERISTICS OF BLOOD, E.G. RED BLOOD CELL FRAGILITY-BACTERIAL CONTAMINATION-EXCESSIVE COOLING-FILTER CLOGGING CORRECTIVE ACTION: AN UPPER LIMIT OF THE AVERAGE CATIONIZATION LEVEL HAS BEEN ESTABLISHED AND IMPLEMENTED IN LOTS NOW BEING MANUFACTURED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY HAD 6 UNITS OF PLASMA DERIVED FROM WHOLE BLOOD WITH A REDTINGE THEY BELIEVE IS DUE TO HEMOLYSIS. THE CUSTOMER HAS NOTICED AN INCREASE IN FILTRATION TIMES,AND RED TINGED PLASMA HAS ALSO INCREASED. 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 FOR RETURN BECAUSE THE CUSTOMER DISCARDED IT. THIS REPORT IS BEING FILED DUE TO INSUFFICIENT INFORMATION PROVIDED AT THIS TIME TO DETERMINE IF A MALFUNCTION WITH THE POTENTIAL FOR DEATH OR INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65944 IMUFLEX DISPOSBLES IMUFLEX WB-RP BLOOD BAG SYSTEM KSR TERUMO BCT 120702KK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other