BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMUFLEX DISPOSABLES

    MDR report key: 3130430 · Received May 24, 2013

    Report

    Report Number
    1722028-2013-01221
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 30, 2013
    Manufacturer
    TERUMO CORPORATION/TERUMO BCT
    Product Code
    CAK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE DISPOSABLE SETS WERE NOT RECEIVED FOR EVALUATION. HEMOLYSIS TESTING WAS PERFORMED ON THE CATIONIZED AND SUPER-CATIONIZED MEMBRANES THAT WERE SAMPLED FROM A TYPICAL HEMOLYZED LOT. HEMOLYSIS WAS 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. WHEN INVESTIGATING SIMILAR REPORTS, IT WAS FOUND THAT THE PRETREATMENT PROCESS OF CATIONIZATION HAD BEEN SWITCHED TO ANOTHER MACHINE. ROOT CAUSE: A DEFINITIVE ROOT CAUSE FOR THIS FAILURE COULD NOT BE DETERMINED. THE FOLLOWING POSSIBLE ROOT CAUSES ARE:1) IT IS POSSIBLE THAT THE CATIONIZATION LEVELS OF THE FILTER IS CAUSING THE HEMOLYSIS. 2) THE PRETREATMENT PROCESS FOR CATIONIZATION WAS MOVED TO ANOTHER MACHINE. 3) HEMOLYSIS CAN ALSO BE CAUSED BY THE FOLLOWING:-CHARACTERISTICS OF BLOOD, E.G. RED BLOOD CELL FRAGILITY-BACTERIAL CONTAMINATION-EXCESSIVE COOLING-FILTER CLOGGING - FILTRATION TIME IS EXTENDED BECAUSE THE FILTER IS LIKELY TO CLOG, AND WHEN RED BLOOD CELLS FLOW THROUGH SUCH A FILTER, A PHYSICAL STRESS ON THE RED BLOOD CELLS MAY CAUSE HEMOLYSIS. CORRECTIVE ACTION:1)THE PRETREATMENT PROCESS OF CATIONIZATION HAS BEEN MOVED BACK TO THE ORIGINAL MACHINE. 2) WHEN AGGREGATION IS OBSERVED IN THE BLOOD PRIOR TO FILTRATION, THE LEUKOREDUCTION FILTER IS LIKELY TO CLOG OR FILTRATION RATE TO SLOW. THE RISK FOR DEVELOPMENT OF BLOOD AGGREGATES CAN BE DECREASED BY AGITATING THE BLOOD DURING AND AT THE END OF BLOOD COLLECTION, SO THAT FILTER BLOCKAGE CAN BE PREVENTED. ALSO, IN ORDER REDUCE THE RISK OF SLOW BLOOD FLOW, THE BAG SHOULD BE AGITATED BEFORE THE START OF FILTRATION TO EVENLY DISPERSE SEPARATED BLOOD COMPONENTS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT FOR THE MONTH OF APRIL, OUT OF 332 UNITS OF WHOLE BLOOD DRAWN, 51 WERE RED-TINGED AND THE CUSTOMER IS DESCRIBING AS HEMOLYSIS. THERE WAS NOT A TRANSFUSION RECIPIENT OR PATIENT INVOLVED AT THE TIME OF THE WHOLE BLOOD CELL PROCESSING INTO PLASMA UNITS, THEREFORE NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT. THE DISPOSABLE SETS ARE NOT AVAILABLE FOR RETURN BECAUSE THEY HAVE BEEN DISCARDED. 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
    231357 IMUFLEX DISPOSABLES IMUFLEX WB-RP BLOOD BAG SYSTEM CAK TERUMO CORPORATION/TERUMO BCT 130311KL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other