BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMUFLEX DISPOSABLES

    MDR report key: 3021610 · Received March 26, 2013

    Report

    Report Number
    1722028-2013-01057
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 1, 2013
    Manufacturer
    TERUMO CORPORATION/TERUMO BCT
    Product Code
    KSR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION: THE DISPOSABLE SET WAS RECEIVED FOR INVESTIGATION. SAMPLES WERE TAKEN FROM THE SET AND TESTED FOR HEMOLYSIS. HEMOLYSIS WAS CONFIRMED, HOWEVER, THE SETS MAY HAVE BEEN AFFECTED BY UNCONTROLLED TEMPERATURES DURING SHIPPING. A SAMPLE FROM THE SET WAS TESTED AND MEASURED IN TERMS OF THE CONCENTRATION OF THE FREE HEMOGLOBIN OF THE SUPERNATANTS. THE CONCENTRATION OF THE SAMPLE WAS 66 MG/DL. THE INFLOW SIDE OF THE LEUKOREDUCTION FILTER WAS VISUALLY EXAMINED. NO AGGREGATES WERE NOTED ON THE FILTER. THREE RETENTION SAMPLES FROM THIS PRODUCTION NUMBER WERE VISUALLY EXAMINED. ONE BAG WAS TESTED FOR SOLUTION VOLUME AND THE OTHER TWO WERE TESTED FOR THE COMPOSITION OF THE SOLUTION. THERE WERE NO ABNORMALITIES IN THE APPEARANCE AND THE MEASURED VALUES CONFORMED TO IN-HOUSE STANDARDS. HEMOLYSIS TESTING WAS PERFORMED ON THE CATIONIZED AND SUPER-CATIONIZED MEMBRANES FROM A TYPICAL HEMOLYZED LOT, WITH HEMOLYSIS FOUND. THE MANUFACTURING AND TESTING RECORDS WERE REVIEWED WITH NO ISSUES NOTED. ROOT CAUSE: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. IT IS POSSIBLE THAT THE HIGH 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 A WHOLE BLOOD UNIT TOOK GREATER THAN 2 HOURS TO FILTER, THEN POST-FILTRATION AND PRIOR TO CENTRIFUGATION, THE UNIT WAS DESCRIBED BY THE CUSTOMER AS SEVERELY HEMOLYZED. 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
    123667 IMUFLEX DISPOSABLES IMUFLEX WB-RP BLOOD BAG SYSTEM KSR TERUMO CORPORATION/TERUMO BCT 120910KL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other