BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORIGEN CRYOSTORE CS500

    MDR report key: 2561657 · Received May 2, 2012

    Report

    Report Number
    MW5025280
    Event Type
    Malfunction
    Date Received
    May 2, 2012
    Date of Event
    April 11, 2012
    Report Date
    April 19, 2012
    Manufacturer
    ORIGEN BIOMEDICAL
    Product Code
    LPZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    WHILE THAWING STEM CELLS FOR BEDSIDE INFUSION OF THAWED CRYOPRESERVED AUTOLOGOUS HPC, APHERESIS CELLULAR THERAPY PRODUCT, (B)(6) DETECTED A FAILURE IN THE FREEZE BAG RESULTING IN LEAKAGE OF THE PRODUCT CONTAINED WITHIN. THE FAILURE OF THE FREEZE BAG OCCURRED IN THE TUBING USED IN THE FINAL STEP OF PROCESSING; IN WHICH THE PRODUCT IS DISPENSED INTO THE FREEZE BAG IN PREPARATION FOR CRYOPRESERVATION. AFTER DISPENSING THE PRODUCT INTO THE FREEZE BAG, THIS TUBING IS HEAT SEALED AT THE BASE SEVERAL TIMES. THE EXCESS TUBING IS THEN DISCONNECTED. THE TUBING BAG DID NOT MAINTAIN ITS PROXIMAL INTEGRITY AS OBSERVED DURING THE THAWING PROCESS. IT WAS DETERMINED BY MEDICAL STAFF NOT TO INFUSE THIS COMPROMISED UNIT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORIGEN CRYOSTORE CS500 FREEZE BAG LPZ ORIGEN BIOMEDICAL CRYOSTORE CS500 K100017-2C

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other