BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMUFLEX DISPOSBLES

    MDR report key: 2964445 · Received February 15, 2013

    Report

    Report Number
    1722028-2013-00941
    Event Type
    Malfunction
    Date Received
    February 15, 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, HOWEVER, THE SETS MAY HAVE BEEN AFFECTED BY UNCONTROLLED TEMPERATURES DURING SHIPPING. NO DEFORMATION OF THE RED BLOOD CELLS WAS NOTED UNDER MAGNIFICATION. 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. THE LOT CONFORMED TO ALL SPECIFICATIONS. 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 RED-TINGED PLASMA POST-FILTRATION. THE CUSTOMER HAS NOTICED AN INCREASE IN FILTRATION TIMES, AND RED TINGED PLASMA OCCURRENCES HAS ALSO INCREASED FOR THEM. HEMOLYSIS WAS DISCOVERED IN THE RETURNED SAMPLE DURING TERUMO BCT'S INTERNAL TESTING. 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. THIS REPORT IS BEING FILED DUE TO HEMOLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67778 IMUFLEX DISPOSBLES IMUFLEX WB-RP BLOOD BAG SYSTEM KSR TERUMO BCT 120618KL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other