BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMUFLEX BLOOD BAG SYSTEM

    MDR report key: 3864304 · Received June 10, 2014

    Report

    Report Number
    1722028-2014-00223
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 14, 2014
    Manufacturer
    TERUMO CORPORATION/TERUMO BCT
    Product Code
    CAK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    STN: (B)(4). INVESTIGATION: PER THE CUSTOMER, THE UNIT EXPERIENCED A LONG FILTRATION TIME. INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE DISPOSABLE SET WAS NOT RETURNED FOR INVESTIGATION. THE LOT NUMBER WAS NOT SPECIFIED BY THE CUSTOMER. RESERVE SAMPLES OF A LOT THAT WAS SHIPPED TO THE CUSTOMER IN THE TIMEFRAME (131008KK) WERE VISUALLY EXAMINED AND THE SOLUTION VOLUME AND SOLUTION COMPOSITION WERE TESTED, WITH NO ABNORMALITIES NOTED. THE MANUFACTURING AND TESTING RECORDS OF LOT 131008KK WERE REVIEWED WITH NO ABNORMALITIES NOTED. ROOT CAUSE: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. POSSIBLE ROOT CAUSES OF HEMOLYSIS ARE: CHARACTERISTICS OF BLOOD, E.G. RED BLOOD CELL FRAGILITY. BACTERIAL CONTAMINATION. EXCESSIVE COOLING. FILTER CLOGGING. THE PRESENCE OF BLOOD AGGREGATION CAN INCREASE THE RISK OF FILTER BLOCKAGE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY HAD A UNIT 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. TERUMO BCT IS AWAITING RETURN OF THE DISPOSABLE SET FOR EVALUATION. 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
    340497 IMUFLEX BLOOD BAG SYSTEM IMUFLEX WB-RP BLOOD BAG SYSTEM WITH LR FILTER CAK TERUMO CORPORATION/TERUMO BCT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other