BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRYOMACS FREEZING BAG 250

    MDR report key: 10188740 · Received June 23, 2020

    Report

    Report Number
    MW5095159
    Event Type
    Malfunction
    Date Received
    June 23, 2020
    Date of Event
    June 10, 2020
    Report Date
    June 19, 2020
    Manufacturer
    MILTENYI BIOTEC INC.
    Product Code
    LPZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2020, THE (B)(6) LABORATORY TECHNOLOGIST WAS VERIFYING THE BACKUP DOSE OF CELLS (AUTOLOGOUS CRYOPRESERVED HPC, APHERESIS) IN STORAGE FOR A PATIENT WHO WILL UNDERGO A SECOND TRANSPLANT AS PART OF THEIR CANCER TREATMENT. THEIR CELLS WERE COLLECTED ON (B)(6) 2014 AND HAVE BEEN IN STORAGE SINCE THIS TIME. UPON VISUALLY INSPECTING THE CRYO BAGS WHILE VERIFYING THE PRODUCT CELLS ARE PRESENT AND INTACT, THE (B)(6) LABORATORY TECHNOLOGIST DISCOVERED A FRACTURE ON ONE OF THE CRYO BAGS EXTENDING FROM THE BASE OF THE BAG TO THE TOP OF THE BAG JUST UNDER THE ACCESS PORT. THE PATIENT HAS AN ACCEPTABLE CELL DOSE TO PROCEED TO TRANSPLANT WITH THE REMAINING INTACT PRODUCT. REVIEW OF DEVIATION REPORTING DOES NOT INDICATE A TREND OF INTEGRITY FAILURES IN ASSOCIATION WITH THE AFFECTED CRYO BAG LOT AND/OR ANY OTHER LOT OF CRYO BAG. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646715 CRYOMACS FREEZING BAG 250 CONTAINER, FROZEN DONOR TISSUE STORAGE LPZ MILTENYI BIOTEC INC. 6121120003

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other