BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORIGEN CRYOSTORE CS500

    MDR report key: 2244046 · Received September 1, 2011

    Report

    Report Number
    MW5022176
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 23, 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 PROCESSING OF HEMATOPOIETIC PROGENITOR CELL APHERESIS AUTOLOGOUS STEM CELL PRODUCT, VISUAL EXAMINATION OF FREEZE BAG REVEALED TWO SMALL VISIBLE WHITE STRANDS WITHIN ORIGEN CRYOSTORE EVA BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORIGEN CRYOSTORE CS500 FREEZE BAG LPZ ORIGEN BIOMEDICAL CS500 K10005-3C

    Patients

    Seq Age Sex Outcome Treatment
    1 Other