BEUDAMED
    FDA Adverse Event Summary report: N

    IMUFLEX DISPOSBLES

    MDR report key: 2935256 · Received January 30, 2013

    Report

    Report Number
    1722028-2013-00032
    Date Received
    January 30, 2013
    Date of Event
    November 1, 2012
    Report Date
    January 3, 2013
    Manufacturer
    TERUMO BCT
    Product Code
    KSR
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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 RECORDS WERE REVIEWED WITH NO ISSUES NOTED. HEMOLYSIS TESTING WAS PERFORMED ON THE CATIONIZED AND SUPER-CATIONIZATED MEMBRANES FROM A TYPICAL HEMOLYZED LOT, WITH HEMOLYSIS FOUND. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION EVALUATION AND CORRECTIVE ACTIONS ARE IN-PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY HAVE DISCARDED 6 UNITS OF PLASMA DERIVED FROM WHOLE BLOOD DUE TO A RED TINGE THEY BELIEVE IS DUE TO HEMOLYSIS.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 MALFUNCTION WITH THE POTENTIAL FOR DEATH OR INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40582 IMUFLEX DISPOSBLES IMUFLEX WB-RP BLOOD BAG SYSTEM KSR TERUMO BCT 120618KL

    Patients

    Seq Age Sex Outcome Treatment
    1