BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    30-70ML CELL FREEZE CRYOGENIC STORAGE CONTAINER

    MDR report key: 7430635 · Received April 13, 2018

    Report

    Report Number
    1066733-2018-00008
    Event Type
    Malfunction
    Date Received
    April 13, 2018
    Date of Event
    February 26, 2018
    Report Date
    April 11, 2018
    Manufacturer
    CHARTER MEDICAL, LTD.
    Product Code
    LPZ
    PMA / PMN Number
    BK100049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR INVESTIGATION/REVIEW. HOWEVER, A PICTURE OF THE BAG WAS FORWARDED BY THE USER FACILITY.THE BAG LOT NUMBER, LOT 150297, WAS VISIBLE FROM THE PICTURE. THE PICTURE INDICATED A BAG WITH AN OPEN INLET TUBE AND THERE WAS NO VISIBLE EVIDENCE OF A USER APPLIED SEAL ON THE INLET TUBE. THE STANDARD METHOD OF USE FOR THE CF-250 IS FOR THE USER TO FILL THE BAG, APPLY A SEAL ON THE INLET TUBE, AND DISCARD THE REMAINING UN-NEEDED TUBING. THE BAG IS THEN FROZEN. THERE ARE ONE OF TWO POTENTIAL SCENARIOS: - THE USER'S TUBE SEAL FAILED. - THE TUBE BROKE BELOW THE USER APPLIED SEAL AFTER THE BAG WAS FROZEN. THE REPORTED LEAK DID NOT OCCUR DURING FILLING OF THE BAG OR DURING THE FREEZING PROCESS, WHICH SUGGESTS THE INLET TUBE BREAK LIKELY OCCURRED AFTER THE BAG WAS FROZEN. THERE WAS NO ADDITIONAL INFORMATION TO SUGGEST AN EXACT ROOT CAUSE FOR THIS REPORT. THERE ARE SEVERAL POTENTIAL ISSUES WHICH COULD CONTRIBUTE TO A FAILURE MODE OF THIS NATURE. - RESIDUAL MOISTURE ON THE OUTSIDE OF THE BAG WHEN IT WAS PLACED INSIDE THE CASSETTE. RESIDUAL MOISTURE COULD CAUSE THE INLET TUBE TO FREEZE/ADHERE TO THE CASSETTE DURING THE FREEZING PROCESS. A CONDITION OF THIS TYPE COULD CAUSE TUBE DAMAGE UPON REMOVAL OF A FROZEN BAG FROM THE CASSETTE. - HANDLING OF THE BAG IN THE FROZEN STATE. THE FILM AND INLET TUBE OF A FROZEN BAG IS FRAGILE - INADVERTENT MANIPULATION OR IMPACT ON THE BAG COULD CAUSE THE INLET TUBE TO FRACTURE. PRECAUTIONS TO HELP PREVENT ISSUES INDICATED ABOVE ARE ADDRESSED IN THE PRODUCT IFU'S.

    Description of Event or Problem · 1

    ON (B)(6) 2018, AFTER THE TECHNICIAN THAWED THE BAG CONTAINING AUTOLOGOUS CELL PRODUCT, A LEAK WAS DETECTED FROM A BROKEN BAG FILLER TUBE. A USER SEALED SEGMENT OF THE TUBE WAS DETACHED FROM THE BAG. THE TECHNICIAN CLAMPED THE REMAINING PORTION OF THE FILLER TUBE TO PREVENT ADDITIONAL LEAKING. THE BAG INITIALLY CONTAINED APPROXIMATELY 60ML OF CELL PRODUCT. THE TECHNICIAN WAS ABLE TO RECOVER 49ML OF CELL PRODUCT, WHICH WAS INFUSED INTO A PATIENT. TOTAL CD34/KG CELLS INFUSED WAS 2.061 E6 INSTEAD OF 2.16 E6 CELLS THAT SHOULD HAVE BEEN INFUSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274122 30-70ML CELL FREEZE CRYOGENIC STORAGE CONTAINER 30-70ML CELL FREEZE CRYOGENIC STORAGE CONTAINER LPZ CHARTER MEDICAL, LTD. CF-250 150297

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR