BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORIGEN CRYOSTORE EVA BAG

    MDR report key: 2237982 · Received September 1, 2011

    Report

    Report Number
    MW5022109
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 11, 2011
    Report Date
    September 1, 2011
    Manufacturer
    ORIGEN BIOMEDICAL
    Product Code
    LPZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING THE INFUSION OF HEMATOPOIETIC PROGENITOR CELL APHERESIS AUTOLOGOUS STEM CELL PRODUCT THE SPIKE ON THE BAXTER Y-TYPE SOLUTION SET INSERTED INTO THE AUTOLOGOUS STEM CELL PRODUCT CONTAINED IN THE ORIGEN CRYOSTORE EVA BAG WAS VISIBLY BENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORIGEN CRYOSTORE EVA BAG ORIGEN CRYO BAG LPZ ORIGEN BIOMEDICAL CS500 K10003-3C AND J1706

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other ORIGEN CRYOSTORE EVA BAG