BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRYOSTORE EVA BAGS

    MDR report key: 2070098 · Received April 21, 2011

    Report

    Report Number
    2070098
    Event Type
    Malfunction
    Date Received
    April 21, 2011
    Date of Event
    January 3, 2011
    Report Date
    April 12, 2011
    Manufacturer
    ORIGEN BIOMEDICAL, INC.
    Product Code
    KSR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING REINFUSION, BAGS WERE UNABLE TO BE SPIKED AS NORMAL DUE TO THE POSITION OF THE PORT ON THE BAGS. AFTER AGITATING THE PORT AREA, AND RE-SPIKING THE BAG, NORMAL FLOW BEGAN, AND REINFUSION CONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYOSTORE EVA BAGS STEM CELL FREEZING BAG KSR ORIGEN BIOMEDICAL, INC. * J1714-4C
    2 CRYOSTORE EVA BAGS STEM CELL FREEZING BAG KSR ORIGEN BIOMEDICAL INC. * J1714-4C

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR