BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMUFLEX WB-RP BLOOD BAG SYSTEM

    MDR report key: 2608896 · Received June 4, 2012

    Report

    Report Number
    1722028-2012-00347
    Event Type
    Other
    Date Received
    June 4, 2012
    Date of Event
    May 8, 2012
    Report Date
    May 9, 2012
    Manufacturer
    TERUMO BCT
    Product Code
    LKN
    PMA / PMN Number
    BN880217
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION EVALUATION AND CORRECTIVE ACTIONS ARE IN-PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION. INVESTIGATION: RESERVE MATERIAL USED IN THE PRODUCTION OF THIS LOT WAS TESTED FOR THE VISCOSITY OF THE PU SOLUTION. THE VISCOSITY OF THE PU SOLUTION CONFORMED TO THE LOWER LIMIT OF THE SPECIFICATION. THE MANUFACTURING RECORDS OF THE FILTERS FOR THIS LOT NUMBER WERE REVIEWED. NO PROBLEMS WERE FOUND. ALSO, THE FILTER MEDIA RECORDS WERE CHECKED, REGARDING PARTICULATE REMOVAL RATES AND CATIONIZATION LEVELS. ALL CONFORMED TO ESTABLISHED STANDARDS. ROOT CAUSE: CATIONIZATION LEVELS, PARTICULATE REMOVAL LEVELS AND THE PU SOLUTION VISCOSITY OF THE FILTER MEDIA WERE WITHIN STANDARDS. REGARDING THE FILTER ASSEMBLIES, THE LOWEST VALUE OF THE AVERAGE OF AVERAGE CATIONIZATION LEVELS WAS ALSO WITHIN THE PROCESS CONTROL STANDARD, BUT WAS AT THE LOWER LIMIT. THEREFORE, THERE IS A POSSIBILITY THAT THE CURRENT LOWER LIMIT OF THE AVERAGE OF AVERAGE CATIONIZATION LEVELS DOES NOT ENSURE SUFFICIENT CAPTURE PERFORMANCE. CORRECTIVE ACTION: THE STANDARD FOR THE LOWER LIMIT OF THE AVERAGE OF THE AVERAGE CATIONIZATION LEVELS FOR THE FILTER ASSEMBLIES, HAS BEEN REVISED TO >0.57 FROM >.056.

    Description of Event or Problem · 1

    THE CUSTOMER REQUESTED AN INVESTIGATION INTO AN UPWARD TREND IN ELEVATED WHITE BLOOD CELL (WBC) COUNTS IN PLATELET PRODUCTS THAT SHE IS EXPERIENCING. 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)(4). THE DISPOSABLE SET IS UNAVAILABLE FOR RETURN FOR EVALUATION. THIS REPORT IS BEING FILED DUE TO AN ALLEGED DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMUFLEX WB-RP BLOOD BAG SYSTEM BLOOD BAG SYSTEM LKN TERUMO BCT 110921KK

    Patients

    Seq Age Sex Outcome Treatment
    1