BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMUFLEX BLOOD BAG SYSTEM

    MDR report key: 3840992 · Received May 30, 2014

    Report

    Report Number
    1722028-2014-00201
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    January 1, 2014
    Report Date
    May 2, 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

    STN#: (B)(4). INVESTIGATION: THE DISPOSABLE SET WAS NOT RETURNED FOR INVESTIGATION. THE RETENTION SAMPLES FROM THIS LOT WERE VISUALLY EXAMINED AND USED TO TEST THE SOLUTION VOLUME AND COMPOSITION. NO ABNORMALITIES WERE FOUND. FILTERING WITH WATER WAS TESTED ON FIVE RETENTION SAMPLES FROM THIS LOT. THE WATER DID NOT FLOW BACK OR PASS BEYOND THE VALVE IN EACH SAMPLE. THE MANUFACTURING RECORDS, TEST RECORDS, AND INSPECTION RECORDS WERE REVIEWED FOR ABNORMALITIES AND NONE WERE FOUND. BLOOD BAGS ARE 100% LEAK TESTED DURING LINE ASSEMBLY, PRIOR TO STERILIZATION. THE CRITERIA FOR THE LEAK TEST ARE PRESCRIBED FOR NOT ALLOWING BLOOD TO PASS OVER THE ONE-WAY VALVE, EVEN IF THE BLOOD FLOWS BACK INTO THE BYPASS LINE. THERE WERE NO DEVIATING EVENTS IN THE MANUFACTURING RECORDS RELATED TO SUCH INCIDENTS. THERE HAVE BEEN NO OTHER SIMILAR COMPLAINTS AGAINST THIS PRODUCTION LOT NUMBER. ROOT CAUSE: A DEFINITIVE ROOT CAUSE FOR THIS FAILURE COULD NOT BE DETERMINED. IT IS POSSIBLE THAT A MANUFACTURING DEFECT COULD HAVE CAUSED THE BLOOD TO FLOW BACKWARD BY PRESSURE FROM THE BLOOD IN THE DONATION BAG DURING FILTRATION, HOWEVER, WITHOUT THE RETURN OF THE SET, THIS CANNOT BE CONFIRMED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY SUSPECTED THE POTENTIAL OF NON-LEUKOREDUCED BLOOD IN THE FILTRATION BAG OF A FILTERED RED BLOOD CELL (RBC) UNIT FROM A WHOLE BLOOD COLLECTION. THEY STATED THAT BLOOD WAS SEEN PAST THE ONE-WAY CHECK VALVE ON THE BYPASS LINE. THERE WAS NOT A TRANSFUSION RECIPIENT OR PATIENT INVOLVED AT THE TIME OF THE RBC FILTRATION,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
    318646 IMUFLEX BLOOD BAG SYSTEM IMUFLEX WB-SP BLOOD BAG SYSTEM WITH LR FILTER CAK TERUMO CORPORATION/TERUMO BCT 130920AF

    Patients

    Seq Age Sex Outcome Treatment
    1 Other