BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRYOCYTE FREEZING CONTAINER

    MDR report key: 496032 · Received November 13, 2003

    Report

    Report Number
    1420141-2003-00095
    Event Type
    Malfunction
    Date Received
    November 13, 2003
    Date of Event
    September 22, 2003
    Report Date
    November 10, 2003
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    KSE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AUTOLOGOUS STEM CELL FROZEN IN SIX BAGS WERE DELIVERED TO THE WARD IN AN MVE SHIPPER. TWO BAGS APPEARED TO HAVE CRACKS AFTER REMOVAL FROM THE SHIPPER. THE CELLS ARE VERY UNLIKELY TO BE REQUIRED NOW AND WILL BE DISCARDED IN 6 MONTHS. THE PT HAS RECEIVED ALLOGRAFT TRANSPLANT AND IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYOCYTE FREEZING CONTAINER CRYOCYTE FREEZING CONTAINER KSE BAXTER HEALTHCARE CORP. NA H02G15050

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN