BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    30 - 70 ML CELL FREEZE CRYOGENIC STORAGE CONTAINER

    MDR report key: 10454053 · Received August 26, 2020

    Report

    Report Number
    1066733-2020-00010
    Event Type
    Malfunction
    Date Received
    August 26, 2020
    Date of Event
    July 17, 2020
    Report Date
    August 26, 2020
    Manufacturer
    CHARTER MEDICAL, LTD.
    Product Code
    LPZ
    PMA / PMN Number
    BK100049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SINGLE, USED CF-250 DEVICE WAS RECEIVED FOR INVESTIGATION. VISUAL EXAMINATION OF THE RETURNED SAMPLE REVEALED (2) FRACTURES IN THE FILM, BELOW ONE OF THE TWO TEAR CAP PORTS, ON BOTH SIDES OF THE BAG. ONE FRACTURE WAS APPROXIMATELY 3/4-INCH LONG AND THE OTHER FRACTURE WAS APPROXIMATELY 3/8-INCH LONG. NO OTHER ISSUES WERE OBSERVED ON THE BAG. SINCE THE LEAK WAS REPORTED DURING THE THAWING PROCESS, THE PRESUMPTION IS MADE THAT THE FRACTURE DID NOT EXIST PRIOR TO FREEZING. A FRACTURE OF THE SIZE OBSERVED ON THE RETURNED COMPLAINT SAMPLE WOULD HAVE RESULTED IN AN OBVIOUS LEAK DURING THE FILLING PROCESS AT THE USER'S FACILITY PRIOR TO FREEZING. USER HANDLING OF THE DEVICE WHILE THE BAG IS IN A FROZEN STATE COULD RESULT IN A FAILURE MODE OF THIS TYPE. THERE ARE SEVERAL POSSIBLE CONDITIONS WHICH COULD CONTRIBUTE TO HANDLING DAMAGE: - RESIDUAL MOISTURE ON THE OUTSIDE OF THE BAG WHEN IT WAS PLACED INSIDE A CASSETTE. RESIDUAL MOISTURE COULD CAUSE THE BAG TO FREEZE/ADHERE TO A CASSETTE DURING THE FREEZING PROCESS. A CONDITION OF THIS TYPE COULD CAUSE FILM DAMAGE UPON REMOVAL OF A FROZEN BAG FROM THE CASSETTE. - HANDLING OF THE BAG IN THE FROZEN STATE. THE FILM OF A FROZEN BAG IS FRAGILE - INADVERTENT MANIPULATION OR IMPACT ON THE BAG COULD CAUSE THE FILM TO FRACTURE. THE PRECAUTIONS INDICATED ABOVE ARE ADDRESSED IN THE PRODUCT IFU'S. A CAPA HAS BEEN ISSUED TO INVESTIGATE REPORTS OF THIS NATURE.

    Description of Event or Problem · 1

    THE END USER REPORTED A LEAK IN THE BAG NEAR THE PORT COMPONENTS. THE LEAK WAS REPORTED DURING THE THAWING PROCESS AFTER THE BAG WAS CRYOGENICALLY FROZEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    918050 30 - 70 ML CELL FREEZE CRYOGENIC STORAGE CONTAINER 30 - 70 ML CELL FREEZE CRYOGENIC STORAGE CONTAINER LPZ CHARTER MEDICAL, LTD. CF-250 701511

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR