BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMUFLEX DISPOSABLES

    MDR report key: 3073587 · Received April 23, 2013

    Report

    Report Number
    1722028-2013-01142
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    March 20, 2013
    Report Date
    March 27, 2013
    Manufacturer
    TERUMO CORPORATION/TERUMO BCT
    Product Code
    KSR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVALUATION AND CORRECTIVE ACTIONS ARE IN-PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 1

    THE DISPOSABLE SET WAS RETURNED FOR INVESTIGATION. AGGREGATION WAS OBSERVED IN THE DONATION BAG. AIR AND FILTRATION TESTS WERE CONDUCTED ON THE SET. NO LEAKS WERE FOUND. WHEN THE FILTER WAS RINSED WITH SALINE A SLOW RATE OF FLOW WAS NOTED. THE RETURNED FILTER WAS DISASSEMBLED AND MUCH BLOOD WAS OBSERVED IN ALL THE FILTER MEMBRANES. THE RETENTION SAMPLES WERE VISUALLY EXAMINED AND USED TO TEST THE SOLUTION VOLUME AND COMPOSITION. NO ABNORMALITIES WERE FOUND. THE MANUFACTURING RECORDS CONCERNING THE LOT IN QUESTION WERE CHECKED. NO ABNORMALITIES WERE FOUND. ROOT CAUSE: A DEFINITIVE ROOT CAUSE REMAINS UNDETERMINED AT THIS TIME. 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 LOADED ON FILTER MEMBRANES. WHEN A PHYSICAL STRESS ON THE FILTER MEMBRANE IS GREATER THAN EXPECTED, TRAPPED LEUKOCYTES ARE PUSHED OUT OF THE FILTER MEMBRANES AND MAY RESULT IN LEUKOCYTE LEAKAGE. FOR THE PURPOSE OF PREVENTING LEUKOCYTE LEAKAGE AND HEMOLYSIS, THE INSTRUCTIONS FOR USE OF THE PRODUCT STATE " CAUTION, DO NOT SQUEEZE OR APPLY PRESSURE ON THE FILTER WHILE IT IS ATTACHED TO THE BAG CONTAINING FILTERED BLOOD."

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN ELEVATED WHITE BLOOD CELL (WBC) CONTENT IN THE RED BLOOD CELL PRODUCT DERIVED FROM WHOLE BLOOD. 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. TERUMO BCT IS AWAITING THE RETURN OF THE DISPOSABLE SET. 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
    175479 IMUFLEX DISPOSABLES IMUFLEX WB-RP BLOOD BAG SYSTEM KSR TERUMO CORPORATION/TERUMO BCT 120918KL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other