BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMUFLEX DISPOSABLES

    MDR report key: 3061253 · Received April 16, 2013

    Report

    Report Number
    1722028-2013-01118
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 18, 2013
    Report Date
    March 29, 2013
    Manufacturer
    TERUMO CORPORATION/TERUMO BCT
    Product Code
    CAK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION. INVESTIGATION:THE DISPOSABLE SET WAS RECEIVED FOR EVALUATION. SAMPLES TAKEN FROM THE RETURNED SET 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 AND TESTING 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 ONE UNIT OF RED-TINGED PLASMA SHE DESCRIBED AS BEING HEMOLYZED. THE UNIT EXPERIENCED A PROLONGED FILTRATION TIME. 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
    162778 IMUFLEX DISPOSABLES IMUFLEX WB-RP BLOOD BAG SYSTEM CAK TERUMO CORPORATION/TERUMO BCT 120918KL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other