BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMUFLEX DISPOSABLES

    MDR report key: 3011557 · Received March 19, 2013

    Report

    Report Number
    1722028-2013-01033
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    January 24, 2013
    Report Date
    February 18, 2013
    Manufacturer
    TERUMO CORPORATION/TERUMO BCT
    Product Code
    CAK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    STN # (B)(4). INVESTIGATION: THE DISPOSABLE SETS WERE NOT RECEIVED FOR EVALUATION. RESERVE SAMPLES FOR THIS LOT WERE VISUALLY EXAMINED, AND THE SOLUTION VOLUME AND SOLUTION COMPOSITION WERE TESTED, WITH NO ABNORMALITIES NOTED. 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 BLOCK AGE CORRECTIVE ACTION: AN UPPER LIMIT OF THE AVERAGE CATIONIZATION LEVEL HAS BEEN ESTABLISHED AND IMPLEMENTED IN LOTS NOW BEING MANUFACTURED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE PRE-TREATMENT PROCESS OF CATIONIZATION HAD BEEN SWITCHED TO ANOTHER MACHINE, AT THE TIME OF THE MANUFACTURE OF THIS LOT. ROOT CAUSE: IN ADDITION TO THE POSSIBLE ROOT CAUSES PREVIOUSLY PROVIDED, THE PRE-TREATMENT PROCESS FOR CATIONIZATION BEING MOVED TO ANOTHER MACHINE IS ANOTHER POSSIBLE ROOT CAUSE. CORRECTIVE ACTION: IN ADDITION TO THE CORRECTIVE ACTION REPORTED IN THE INITIAL REPORT, THE PRE-TREATMENT PROCESS OF CATIONIZATION HAS ALSO BEEN MOVED BACK TO THE ORIGINAL MACHINE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED 2 UNITS OF PINK-TINGED PLASMA. THERE WAS NOT A TRANSFUSION RECIPIENT OR PATIENT INVOLVED AT THE TIME OF THE WHOLE BLOOD CELLP ROCESSING INTO PLASMA UNITS, THEREFORE, NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT. THE DISPOSABLE SETS WERE UNAVAILABLE FOR RETURN BECAUSE THE CUSTOMER DISCARDED THEM. 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
    113706 IMUFLEX DISPOSABLES IMUFLEX WB-RP BLOOD BAG SYSTEM CAK TERUMO CORPORATION/TERUMO BCT 120730KL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other