BEUDAMED
    FDA Adverse Event Summary report: N

    IMUFLEX DISPOSBLES

    MDR report key: 2920420 · Received January 17, 2013

    Report

    Report Number
    1722028-2013-00021
    Date Received
    January 17, 2013
    Date of Event
    December 20, 2012
    Report Date
    December 21, 2012
    Manufacturer
    TERUMO BCT
    Product Code
    LKN
    Report Source
    Manufacturer report
    Reporter Location
    NH, 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 FILED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THREE SETS WERE RECEIVED FOR INVESTIGATION. THE SETS WERE VISUALLY INSPECTED AND NO ANOMALIES WERE FOUND. SAMPLES WERE TAKEN FROM ONE OF THE SETS AND TESTED FOR HEMOLYSIS. HEMOLYSIS WAS CONFIRMED, HOWEVER THE SETS MAY HAVE BEEN AFFECTED BY UNCONTROLLED TEMPERATURES DURING SHIPPING. HEMOLYSIS TESTING WAS PERFORMED ON THE CATIONIZATION AND SUPER-CATIONIZATION MEMBRANES, WITH HEMOLYSIS FOUND. RESERVE SAMPLES FOR THIS LOT WERE VISUALLY EXAMINED, AND THE SOLUTION VOLUME AND SOLUTION COMPOSITION WERE TESTED, WITH NO ABNORMALITIES NOTED. THE MANUFACTURING RECORDS WERE REVIEWED WITH NO ISSUES NOTED. THE NUMBER OF REPORTS REGARDING THE INCIDENT CONCERNED HAS INCREASED IN THE LOTS MANUFACTURED AFTER THE NEW SPECIFICATION (I.E. THE LOWER LIMIT OF THE "AVERAGE CATIONIZATION LEVEL", GREATER THAN EQUAL TO 0.570) WAS ESTABLISHED. 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 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 FOUR INSTANCES OF RED-TINGED PLASMA THAT THEY ARE ALLEGING ARE HEMOLYZED. THE ALLEGED HEMOLYSIS WAS FOUND POST-DONATION, DURING COMPONENT PREPARATION. THERE WAS NOT A TRANSFUSION RECIPIENT OR PATIENT INVOLVED AT THE TIME OF THE COMPONENT PREPARATION, THEREFORE, NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT. TWO OF THE DISPOSABLE SETS ARE AVAILABLE FOR RETURN. THIS REPORT IS BEING FILED DUE TO ALLEGED HEMOLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26710 IMUFLEX DISPOSBLES IMUFLEX WB-RP BLOOD BAG SYSTEM LKN TERUMO BCT 120709KK

    Patients

    Seq Age Sex Outcome Treatment
    1