BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMUFLEX DISPOSBLES

    MDR report key: 3011380 · Received March 19, 2013

    Report

    Report Number
    1722028-2013-01028
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    January 23, 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

    (B)(4) INVESTIGATION: DISPOSABLE SETS WERE RECEIVED FOR INVESTIGATION. SAMPLES FROM THE SETS WERE TESTED AND MEASURED IN TERMS OF THE CONCENTRATIONS OF THE FREE HEMOGLOBIN OF THE SUPERNATANTS. THE CONCENTRATION OF ALL THE SAMPLES FELL WITHIN THE RANGE OF 20 MG/DL TO 160 MG/DL. 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.

    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 3 UNITS OF PINK-TINGED PLASMA. 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. 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
    113233 IMUFLEX DISPOSBLES IMUFLEX WB-RP BLOOD BAG SYSTEM CAK TERUMO CORPORATION/TERUMO BCT 120723KK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other