BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    30-70ML CELL FREEZE CRYOGENIC STORAGE CONTAINER/3 LEADS

    MDR report key: 8110122 · Received November 28, 2018

    Report

    Report Number
    1066733-2018-00022
    Event Type
    Malfunction
    Date Received
    November 28, 2018
    Date of Event
    October 19, 2018
    Report Date
    November 26, 2018
    Manufacturer
    CHARTER MEDICAL, LTD.
    Product Code
    LPZ
    PMA / PMN Number
    BK100049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    A SINGLE, USED SAMPLE WAS RECEIVED FOR INVESTIGATION. THE BAG WAS CHARGED WITH COMPRESSED AIR AND LEAK TESTED UNDER WATER; A LEAK WAS DISCOVERED FROM THE RIGHT TOP CORNER OF THE BAG. THE AREA WHERE THE OBSERVED LEAK ORIGINATED WAS EXAMINED, USING A MAGNIFICATION INSPECTION LAMP, AND A HOLE WAS VERIFIED IN THE FILM. THE EXAMINATION ALSO REVEALED A FILM OFF-SET ISSUE IN THE PERIMETER WELD AT THE PORT SECTION OF THE BAG. THE OFFSET IS INDICATIVE OF A FILM MIS-ALIGNMENT ISSUE, WHICH WOULD HAVE OCCURRED DURING THE MANUFACTURING PROCESS. DURING THE MANUFACTURING PROCESS, THE BAG IS PLACED INTO TOOLING FOR A WELDING PROCESS, WHICH REQUIRES MANUAL FILM ALIGNMENT. AS A RESULT OF THE FILM MISALIGNMENT OBSERVED ON THE RETURNED SAMPLE, THE MANUFACTURING TOOLING LIKELY PLACED STRESS ON THE FILM AT THE HOLE LOCATION AND PRODUCED A TEAR, OR WEAK AREA, IN THE FILM.

    Description of Event or Problem · 1

    THE USER OF THE DEVICE DISCOVERED BLOOD PRODUCT LEAKING AT THE EDGE OF THE BAG. THERE WAS NO REPORT OF AN ADVERSE EVENT OR NEED FOR ADDITIONAL MEDICAL INTERVENTION AS A RESULT OF THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    949395 30-70ML CELL FREEZE CRYOGENIC STORAGE CONTAINER/3 LEADS 30-70ML CELL FREEZE CRYOGENIC STORAGE CONTAINER/3 LEADS LPZ CHARTER MEDICAL, LTD. CF-250-3L 150349

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR