BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRYOCYTE FREEZING CONTAINER 250ML

    MDR report key: 702055 · Received February 13, 2006

    Report

    Report Number
    1420141-2006-00006
    Event Type
    Malfunction
    Date Received
    February 13, 2006
    Date of Event
    January 17, 2006
    Report Date
    January 25, 2006
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KSE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    1 BAG NOTED TO BE CRACKED WHEN READY TO THAW ON 01/17/2006. PATIENT RECEIVED PRODUCT FROM BAG. UNKNOWN IF PATIENT RECEIVED PRODUCT FROM BAG. UNKNOWN IF PATIENT RECEIVED ANY MEDICAL INTERVENTION AS A RESULT OF THIS EVENT. SAMPLE IS AVAILABLE FOR EVALUATION. THERE IS NO PATIENT INFORMATION AVAILABLE. PATIENT HAD CELLS FOR TRANSPLANTATION AS THERE WERE ADDITIONAL BAGS GIVEN TO PATIENT ALONG WITH CRACKED BAG. VOLUME OF PRODUCT IN BAG WAS 50ML. A METAL CASSETTE IS USED FOR FREEZING AND STORAGE. BLOOD CENTER USES A MECHANICAL FREEZER FOR THE FIRST HOUR AND THEN TRANSFER BAGS TO LIQUID NITROGEN VAPOR PHASE STORAGE. STORAGE WAS FOR 3 WEEK PERIOD. COLLECTION OF PRODUCT WAS IN 12/2005 AND PRODUCT WAS TRANSFUSED TO PATIENT ON 01/17/2006.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYOCYTE FREEZING CONTAINER 250ML CRYOCYTE BAGS KSE BAXTER HEALTHCARE CORPORATION NA H05E26033

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN