BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMUFLEX DISPOSABLES

    MDR report key: 3073559 · Received April 23, 2013

    Report

    Report Number
    1722028-2013-01141
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 27, 2013
    Manufacturer
    TERUMO CORPORATION/TERUMO BCT
    Product Code
    CAK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE SETS WERE RETURNED FOR INVESTIGATION. THE SETS WERE VISUALLY INSPECTED FOR MISASSEMBLIES, KINKS, MISSING PARTS AND GENERAL DEFECTS AND NONE WERE OBSERVED. THE PLASMA DIDAPPEAR TO BE HEMOLYZED AS REPORTED BY THE CUSTOMER. 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 AGGREGATES WERE NOTED AT THE FILTERS. RESERVE SAMPLES FOR A TYPICAL HEMOLYZED LOT WERE USED FOR HEMOLYSIS TESTING. HEMOLYSIS TESTING WAS PERFORMED ON THE CATIONIZED AND SUPER-CATIONIZED 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 - 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 2 PLASMA UNITS THAT WERE HEMOLYZED POST-CENTRIFUGATION. THE UNITS TOOK LONGER THAN ONE HOUR TO FILTER. 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 A DEVICE MALFUNCTION THAT HAS THE POTENTIAL FOR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174686 IMUFLEX DISPOSABLES IMUFLEX WB-RP BLOOD BAG SYSTEM CAK TERUMO CORPORATION/TERUMO BCT 120924KK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other