BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUFLEX BLOOD BAG SYSTEM

    MDR report key: 3051397 · Received April 10, 2013

    Report

    Report Number
    1722028-2013-01089
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    February 1, 2013
    Report Date
    March 14, 2013
    Manufacturer
    TERUMO CORPORATION/TERUMO BCT
    Product Code
    KSR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE CUSTOMER BELIEVES THIS COULD POSSIBLY BE A CHANGE IN STRIPPING PROCEDURES VERSUS A DISPOSABLE ISSUE. 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. THE MANUFACTURING RECORDS AND TESTING AND INSPECTION RECORDS WERE REVIEWED. THE LOT CONFORMED TO ALL SPECIFICATIONS. ROOT CAUSE: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. BASED ON THE INFORMATION PROVIDED FROM THE CUSTOMER, THE TUBING WAS STRIPPED IMMEDIATELY AFTER COLLECTION. IF BLOOD FLOW OCCURS BEYOND THE CLIP WHILE STRIPPING, THERE IS A RISK OF CAUSING HEMOLYSIS. HEMOLYSIS CAN ALSO BE CAUSED BY THE FOLLOWING:-CHARACTERISTICS OF BLOOD, E.G. RED BLOOD CELL FRAGILITY-BACTERIAL CONTAMINATION-EXCESSIVE COOLING

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A UNIT OF PLASMA DERIVED FROM WHOLE BLOOD THAT HAD HEMOLYSIS. THEY HAVE NOT FORMALLY TESTED THE UNIT FOR HEMOLYSIS, BUT IT MET THE VISUAL CRITERIA FOR HEMOLYSIS. THERMOLYSIS OCCURRED POST-COLLECTION AND PRE-FILTRATION OF THE UNIT. 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. THE DISPOSABLE SET IS UNAVAILABLE FOR RETURN BECAUSE THE CUSTOMER DISCARDED IT. 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
    148282 TERUFLEX BLOOD BAG SYSTEM TERUFLEX CPD/OPTISOL 500ML TRIPLE BLOOD COLLECTION SET KSR TERUMO CORPORATION/TERUMO BCT 120820GC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other