BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORIGEN EVOLVE 3000 ML CRYOPRESERVATION BAG

    MDR report key: 10699110 · Received October 16, 2020

    Report

    Report Number
    MW5097317
    Event Type
    Injury
    Date Received
    October 16, 2020
    Date of Event
    September 30, 2020
    Report Date
    October 9, 2020
    Manufacturer
    ORIGEN BIOMEDICAL, INC.
    Product Code
    KSR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 1

    EACH OF THE THREE PARTS BECOME UNATTACHED FROM THE STEM CELL TRANSFER BAG CONTAINING 1908 ML OF PERIPHERAL BLOOD DONOR STEM CELLS. THIS PRODUCT WAS COLLECTED FROM A VOLUNTEER DONOR FOR THE (B)(6) INTENDED FOR POTENTIAL LIFE- SAVING TRANSPLANTATION. FAILURE OF THIS PRODUCT RESULTED IN CONCERNS FOR PRODUCT CONTAMINATION, REDUCED PRODUCT VOLUME AND VIABILITY, ADDITIONAL LEAVING INCLUDING BACTERIAL CULTURES, CELL COUNTS AND DELAYS IN CARE OF THE INTENDED PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1152785 ORIGEN EVOLVE 3000 ML CRYOPRESERVATION BAG CONTAINER, EMPTY, FOR COLLECTION & PROCESSING OF BLOOD & BLOOD COMPONENTS KSR ORIGEN BIOMEDICAL, INC. EV3000N R29410-4N

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention