BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMUFLEX DISPOSABLES

    MDR report key: 3021218 · Received March 26, 2013

    Report

    Report Number
    1722028-2013-01054
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    February 28, 2013
    Report Date
    February 28, 2013
    Manufacturer
    TERUMO CORPORATION/TERUMO BCT
    Product Code
    KSR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE 36 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. 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. 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. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION: THE CUSTOMER RETURNED (B)(4) DISPOSABLE SETS FOR EVALUATION. 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 ARE AVERAGING A DISCARD RATE OF 20-30% OF PLASMA COLLECTED 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. 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
    123576 IMUFLEX DISPOSABLES IMUFLEX WB-RP BLOOD BAG SYSTEM KSR TERUMO CORPORATION/TERUMO BCT 120820KL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other