BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC

    MDR report key: 11261212 · Received January 29, 2021

    Report

    Report Number
    MW5099119
    Event Type
    Injury
    Date Received
    January 29, 2021
    Date of Event
    December 15, 2020
    Report Date
    January 28, 2021
    Manufacturer
    TERUMO BCT INC.
    Product Code
    GKT
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 1

    UPON DEBULKING A MARROW ON THE COBE CELL WASHER, A LINE BECAME LOOSE AND DISCONNECTED FROM THE COBE BAG. WE OPENED UP ANOTHER BAG OF THE SAME LOT AND TRIED TO RE-CREATE THE EVENT, BUT COULDN'T GET THE LINE TO LOOSEN OR PULL AWAY FROM THE BAG. WE THINK IT WAS A FAULTY BAG INITIALLY. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145595 SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC GKT TERUMO BCT INC. 90819 09D15004

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention