BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMUFLEX BLOOD BAG SYSTEM

    MDR report key: 4638460 · Received March 27, 2015

    Report

    Report Number
    1722028-2015-00113
    Event Type
    Malfunction
    Date Received
    March 27, 2015
    Date of Event
    March 4, 2015
    Report Date
    March 4, 2015
    Manufacturer
    TERUMO CORPORATION/TERUMO BCT
    Product Code
    CAK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION: TEN DISPOSABLE SETS WERE RETURNED FOR EVALUATION. SAMPLES WERE TESTED AND MEASURED IN TERMS OF THE CONCENTRATIONS OF THE FREE HEMOGLOBIN OF THE SUPER NATANTS. THE CONCENTRATION OF THE 10 SAMPLES WERE:SAMPLE 1 (W0013 15 001484): 20.5 MG/DLSAMPLE 2 (W0013 15 001485): 18.7 MG/DLSAMPLE 3 (W0013 15 001488): 64.3 MG/DLSAMPLE 4 (W0013 15 001492): 42.7 MG/DLSAMPLE 5 (W0013 15 001501): 13.6 MG/DLSAMPLE 6 (W0013 15 001514): 27.6 MG/DLSAMPLE 7 (W0013 15 001516): 62.3 MG/DLSAMPLE 8 (W0013 15 001522): 40.7 MG/DLSAMPLE 9 (W0013 15 001526): 37.2 MG/DLSAMPLE 10 (W0013 15 001528):19.4 MG/DL THE MANUFACTURING AND TESTING RECORDS WERE REVIEWED WITH NO ISSUES NOTED. NO SIMILAR REPORTS HAVE BEEN RECEIVED REGARDING THIS LOT NUMBER. 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 ANOMALIES IN THE APPEARANCE AND MEASURED VALUE CONFORMED TO IN-HOUSE STANDARDS. REGARDING SAMPLE 2, SAMPLE 5, AND SAMPLE 10, THE CONCENTRATION OF FREE HEMOGLOBIN OF THE PLASMA WAS LESS THAN 20 MG/DL AND RED BLOOD CELL SEDIMENTATION WAS OBSERVED IN THE CONICAL TUBE IN EACH SAMPLE AFTER CENTRIFUGATION, AND THEREFORE IT IS INFERRED THAT RED CELL CONTAMINATION WAS ONE OF THE FACTORS OF THE INCIDENT OBSERVED. ROOT CAUSE: A DEFINITIVE ROOT CAUSE FOR RED CELL CONTAMINATION COULD NOT BE DETERMINED. THE FOLLOWING ARE GENERAL CAUSES OF RED BLOOD CELL CONTAMINATION: CHARACTERISTICS OF BLOOD THERE IS A POSSIBILITY THAT RED BLOOD CELLS DO NOT FULLY SETTLE OUT AND GET MIXED IN WITH PLASMA IF DONOR¿S BLOOD IS CHARACTERISTIC OF HEAVY MILKY PLASMA. TERMINATION CONDITION OF PLASMA SEPARATION IF PLASMA IS THOROUGHLY SEPARATED DURING PLASMA SEPARATION, RED BLOOD CELLS CAN GET MIXED WITH THE PLASMA. IT IS MORE OBVIOUS WHEN THE SEPARATION SPEED IS GREATER. THE IMUFLEX WB-RP REMOVES PLATELET (I.E. MAIN COMPONENT OF BUFFY COAT) BY THE LEUKO REDUCTION FILTER AT PRE-FILTRATION. THEREFORE, COMPARED TO THE WHOLE BLOOD IN A BLOOD BAG WITHOUT LEUKO REDUCTION FILTER OR THE IMUFLEX WB-SP, RED BLOOD CELLS ARE LIKELY TO GET MIXED WITH PLASMA. RED BLOOD CELL REMAINING IN THE UPPER PART OF A BAG AFTER CENTRIFUGATION IF WHOLE BLOOD IS POOLED INSIDE THE OUTLET PORT AND CENTRIFUGED, THE WHOLE BLOOD STAYS AS IT IS DURING CENTRIFUGATION, AND RED BLOOD CELLS MAY BE GOT CAUGHT IN THE FLOW OF PLASMA AND GET MIXED WITH THE PLASMA IN SEPARATING PLASMA. IN ADDITION, THERE IS A POSSIBILITY OF ABNORMALITY IN THE COLOR TONE OF PLASMA CAUSED BY EXHIBITING A STRONG YELLOW COLOR LIKE HYPERBILIRUBINEMIA. IN REGARD TO THE SEVEN OTHER SAMPLES, THERE IS A POSSIBILITY THAT A COMBINATION OF THE FOLLOWING COMMON FACTORS OF RED-TINGED BLOOD PRODUCTS HAS CAUSED THE REPORTED INCIDENT: ROOT CAUSE: IN REGARD TO THE SEVEN OTHER SAMPLES, A DEFINITIVE ROOT CAUSE OF RED-TINGED BLOOD PRODUCT COULD NOT BE DETERMINED AT THIS TIME. THE FOLLOWING POSSIBLE ROOT CAUSES ARE: CHARACTERISTICS OF BLOOD E.G. RED BLOOD CELL FRAGILITY. BACTERIAL CONTAMINATION. EXCESSIVELY COOLING. FILTER OCCLUSION.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY HAD (B)(4) UNITS OF PLASMA DERIVED FROM WHOLE BLOOD WITH A RED TINGE THEY BELIEVE IS DUE TO HEMOLYSIS. THERE WAS NOT A TRANSFUSION RECIPIENT OR PATIENT INVOLVED AT THE TIME OF WHOLE BLOOD PROCESSING,THEREFORE NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT. THE DISPOSABLE SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206735 IMUFLEX BLOOD BAG SYSTEM IMUFLEX WB-RP BLOOD BAG SYSTEM WITH LR FILTER CAK TERUMO CORPORATION/TERUMO BCT 140728KK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other