BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMUFLEX BLOOD BAG SYSTEM

    MDR report key: 3936182 · Received July 15, 2014

    Report

    Report Number
    1722028-2014-00267
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 18, 2014
    Manufacturer
    TERUMO CORPORATION/TERUMO BCT
    Product Code
    CAK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE DISPOSABLE SET WAS RETURNED FOR INVESTIGATION. AGGREGATION WAS OBSERVED IN THE DONATION BAG. THE LEUKOREDUCTION FILTER WAS TESTED FOR FLOW RATE AND AIR LEAKS. LITTLE FLOW WAS OBSERVED AND IT WAS CONFIRMED THERE WERE NO AIR LEAKS. THE MANUFACTURING RECORDS, TEST RECORDS AND INSPECTION RECORDS WERE REVIEWED FOR ABNORMALITIES AND NONE WERE FOUND. THE RECORDS REGARDING THE PARTICULATE REMOVAL RATES OF THE FILTER MEMBRANES WERE ALSO REVIEWED. ALL MEMBRANES CONFORMED TO ESTABLISHED SPECIFICATIONS. THERE HAVE BEEN NO OTHER SIMILAR COMPLAINTS AGAINST THIS PRODUCTION LOT NUMBER. ROOT CAUSE: THE ROOT CAUSE FOR THE LEUKOREDUCTION FAILURE IS UNDETERMINED. LEUKOCYTE LEAKAGE IS COMMONLY CAUSED BY THE FOLLOWING FACTORS. CHARACTERISTICS OF BLOOD THERE IS A POSSIBILITY OF LEUKOCYTE LEAKAGE DUE TO THE DONOR'S BLOOD CHARACTERISTICS. PRESSURE LOAD ON FILTER MEMBRANES WHEN A PHYSICAL STRESS ON THE FILTER MEMBRANES IS GREATER THAN EXPECTED, THE TRAPPED LEUKOCYTES ARE PUSHED OUT OF THE FILTER AND MAY RESULT IN LEUKOCYTE LEAKAGE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ELEVATED WHITE BLOOD CELL (WBC) CONTENT IN A FILTERED RED BLOOD CELL UNIT. THERE WAS NOT A TRANSFUSION RECIPIENT OR PATIENT INVOLVED AT THE TIME OF THE RESIDUAL WBC TESTING, THEREFORE NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT. DONOR UNIT #: (B)(6). 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
    412735 IMUFLEX BLOOD BAG SYSTEM IMUFLEX WB-RP BLOOD BAG SYSTEM WITH LR FILTER CAK TERUMO CORPORATION/TERUMO BCT 131021KK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other