BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMUFLEX BLOOD BAG SYSTEM

    MDR report key: 3911261 · Received July 2, 2014

    Report

    Report Number
    1722028-2014-00260
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 12, 2014
    Manufacturer
    TERUMO CORPORATION/TERUMO BCT
    Product Code
    CAK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION: THE DISPOSABLE SET WAS UNAVAILABLE FOR RETURN AND INVESTIGATION. THE MANUFACTURING RECORDS, TEST RECORDS AND INSPECTION RECORDS WERE REVIEWED FOR ABNORMALITIES AND NONE WERE FOUND. RESERVE SAMPLES FOR THIS LOT WERE TESTED FOR THE SAME FILTERING ISSUE. NO SIMILAR ISSUES WERE NOTED WITH THESE SAMPLES. THERE HAVE BEEN NO OTHER SIMILAR COMPLAINTS AGAINST THIS PRODUCTION LOT NUMBER. ROOT CAUSE: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. BASED ON THE CUSTOMER DESCRIPTION, IT IS POSSIBLE THAT A MANUFACTURING DEFICIENCY CAUSED THE CLOSING FUNCTION OF THE TUBE TO NOT FULLY WORK AND CONSEQUENTLY BLOOD FLOWED BACKWARD BY PRESSURE OF THE BLOOD IN THE DONATION BAG DURING FILTRATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FILTRATION ISSUE WITH A WHOLE BLOOD UNIT. DURING FILTRATION, THE OPERATOR NOTICED THE ONE WAY CHECK VALVE DID NOT PROPERLY STOP THE BLOOD PRODUCT AND THE BLOOD FLOWED INTO THE BYPASS LINE. PER THE CUSTOMER, THE UNFILTERED BLOOD MAY HAVE ENTERED INTO THE FILTERED PRODUCT RESULTING IN POTENTIAL WBC CONTAMINATION IN THE FINAL PRODUCT. THE PRODUCT WAS DISCARDED BY THE CUSTOMER. THERE WAS NOT A TRANSFUSION RECIPIENT OR PATIENT INVOLVED AT THE TIME OF THE WHOLE BLOOD PROCESSING, THEREFORE, NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT. DONOR UNIT #: (B)(6) THE DISPOSABLE KIT IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER. 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
    385967 IMUFLEX BLOOD BAG SYSTEM IMUFLEX WB-SP BLOOD BAG SYSTEM WITH LR FILTER CAK TERUMO CORPORATION/TERUMO BCT 131115AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other