BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBE BLOOD CELL PROCESSING SET

    MDR report key: 21197238 · Received January 21, 2025

    Report

    Report Number
    MW5164928
    Event Type
    Injury
    Date Received
    January 21, 2025
    Date of Event
    October 18, 2024
    Report Date
    January 14, 2025
    Manufacturer
    TERUMO BCT, INC.
    Product Code
    GKT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    501
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    UPON DEBULKING A MARROW PRODUCT FOR BUFFY COATING ON THE COBE CELL WASHER, THE COBE CELL PROCESSING BAG SPLIT AT THE JUNCTION. A NEW PROCESSING BAG WAS USED TO COMPLETE THE BUFFY COATING PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669484 COBE BLOOD CELL PROCESSING SET SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC GKT TERUMO BCT, INC. 90819 09G15005

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention