BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMUFLEX DISPOSABLES

    MDR report key: 3021317 · Received March 26, 2013

    Report

    Report Number
    1722028-2013-01056
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    February 1, 2013
    Report Date
    March 1, 2013
    Manufacturer
    TERUMO CORPORATION/TERUMO BCT
    Product Code
    CAK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - INVESTIGATION: THE DISPOSABLE SETS WERE NOT RECEIVED FOR EVALUATION. THE LOT NUMBER WAS NOT SPECIFIED BY THE CUSTOMER, SO RESERVE SAMPLES FOR LOT 120723KL, WHICH HAD BEEN PREVIOUSLY REPORTED BY THE CUSTOMER, WERE VISUALLY EXAMINED, AND THE SOLUTION VOLUME AND SOLUTION COMPOSITION WERE TESTED, WITH NO ABNORMALITIES NOTED. THE MANUFACTURING RECORDS WERE REVIEWED. THE LOT CONFORMED TO ALL SPECIFICATIONS. RESERVE SAMPLES FOR A TYPICAL HEMOLYZED LOT WERE USED FOR TESTING. HEMOLYSIS TESTING WAS PERFORMED ON THE CATIONIZED AND SUPER-CATIONIZED MEMBRANES, 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 - THE PRESENCE OF BLOOD AGGREGATION CAN INCREASE THE RISK OF FILTER BLOCKAGE 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 HAVE DISCARDED 307 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 SETS ARE UNAVAILABLE FOR 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
    124161 IMUFLEX DISPOSABLES IMUFLEX WB-RP BLOOD BAG SYSTEM CAK TERUMO CORPORATION/TERUMO BCT UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other