BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMUFLEX BLOOD BAG SYSTEM

    MDR report key: 7685588 · Received July 13, 2018

    Report

    Report Number
    9681839-2018-00049
    Event Type
    Malfunction
    Date Received
    July 13, 2018
    Date of Event
    June 17, 2018
    Report Date
    July 13, 2018
    Manufacturer
    TERUMO CORPORATION
    Product Code
    CAK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    STN # BN 880217 TERUMO BCT, INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF FUJINOMIYA FACTORY OF TERUMOCORP., (MANUFACTURER). EXEMPTION NUMBER: E2015056.INVESTIGATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION AND INVESTIGATION: THE WHOLE BLOOD COLLECTION SET WAS NOT RETURNED TO TERUMO BCT FOR EVALUATION. THE MANUFACTURING RECORDS, TEST RECORDS, AND INSPECTION RECORDS FOR THE REPORTED LOT NUMBER WERE REVIEWED FOR ABNORMALITIES AND NONE WERE FOUND. IN ADDITION, THE DOPE MATERIAL USED WERE INVESTIGATED AND FOUND THAT THE VISCOSITY OF PU SOLUTION OF DOPE MATERIAL CONFORMED TO THE STANDARDS. THE RECORDS REGARDING THE PARTICULATE REMOVAL RATES OF THE FILTER MEMBRANES OF THE REPORTED LOT NUMBER WERE REVIEWED AND ALL MEMBRANES CONFORMED TO ESTABLISHED SPECIFICATION. SHIPPING TESTING WAS PERFORMED ON THE RESERVE SAMPLES FROM THE REPORTED LOT NUMBER. THE RESERVE SAMPLES WERE ALSO VISUALLY EXAMINED, AND THE SOLUTION VOLUME AND SOLUTION COMPOSITION WERE TESTED WITH NO ABNORMALITIES NOTED. ALL PRODUCT CONFORMED TO THE ESTABLISHED SPECIFICATION. ROOT CAUSE: A DEFINITIVE ROOT CAUSE FOR THE OBSERVED ELEVATED WBC COUNT REMAINS UNDETERMINED AT THIS TIME. BASED ON THE AVAILABLE INFORMATION, IT CANNOT BE RULED OUT THAT THE HIGHER-THAN-EXPECTED WBC CONTENT IN THE WHOLE BLOOD PRODUCT COULD BE DUE TO AN OCCLUSION,BLOOD MAY HAVE BEEN FILTERED BY A SMALLER THAN USUAL FILTER AREA. AS A RESULT, LINEAR SPEED MAY HAVE INCREASED, AND LEUKOCYTE LEAKAGE MAY HAVE OCCURRED. AS AN INCREASE OF WBC CONTAMINATION COMPLAINTS WERE NOTED FROM PREVIOUS LOT NUMBERS, FURTHER INVESTIGATION WAS PERFORMED. INVESTIGATION RESULTS INDICATED THAT THE CAUSE OF HIGHER-THAN-EXPECTED WBC CONTENT IN THE WHOLE BLOOD PRODUCT WAS DUE TO THE MAXIMUM PORE SIZE OF THE FILTER MEMBRANE IS LIKELY TO INCREASE ACCORDING TO THE COMBINATION OF MULTIPLE PARAMETERS IN MANUFACTURE OF LEUKOREDUCTION FILTER MEMBRANES AND WBC CONTAMINATION IS LIKELY TO OCCUR FREQUENTLY IN THE PRODUCT LOTS OF WHICH THE MAXIMUM PORE SIZE OF THE FILTER MEMBRANE HAS INCREASED. THE INSTRUCTIONS FOR USE PROVIDE A CAUTION TO NOT SQUEEZE OR APPLY PRESSURE TO THE FILTER WHILE IT IS ATTACHED TO THE BAG CONTAINING THE FILTERED BLOOD AND ALSO TO CLAMP THE BLOOD-FILLED TUBING BEFORE BLOOD ENTERS THE FILTER IN ORDER TO AVOID LEUKOCYTE LEAKAGE. CORRECTIVE ACTION: AN INTERNAL CAPA HAS BEEN INITIATED TO REVIEW THE MAXIMUM PORE SIZE OF THE FILTER MEMBRANE AND THE LIKELIHOOD OF AN INCREASE ACCORDING TO THE COMBINATION OF THE MULTIPLE PARAMETERS. IN ADDITION, THE WBC CONTAMINATION IS LIKELY TO OCCUR FREQUENTLY IN THE PRODUCT LOTS OF WHICH THE MAXIMUM PORE SIZE OF THE FILTER MEMBRANE HAS INCREASED. TO ACHIEVE A RESOLUTION, MANUFACTURING SPECIFICATIONS WERE UPDATED TO NARROW THE RANGE OF THE PARAMETERS IN THE MANUFACTURE OF FILTER MEMBRANES AND IT WAS CONFIRMED THAT THE APPROPRIATE LEVEL OF THE MAXIMUM PORE SIZE OF THE FILTER MEMBRANE WAS ACHIEVED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED ELEVATED WHITE BLOOD CELL (WBC) CONTENT IN A FILTERED WHOLE BLOOD UNIT. 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. DONOR UNIT #: (B)(6). THE WHOLE BLOOD COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530465 IMUFLEX BLOOD BAG SYSTEM IMUFLEX WB-RP BLOOD BAG SYSTEM WITH LR FILTER CAK TERUMO CORPORATION 170821KK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other