BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8077389 · Received November 16, 2018

    Report

    Report Number
    1066733-2018-00021
    Event Type
    Malfunction
    Date Received
    November 16, 2018
    Date of Event
    October 17, 2018
    Report Date
    November 16, 2018
    Manufacturer
    CHARTER MEDICAL, LTD.
    Product Code
    LPZ
    PMA / PMN Number
    BK100049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS NOT RETURNED FOR INVESTIGATION, HOWEVER THE USER PROVIDED PICTURES OF A BAG FROM LOT 149037. THE PICTURES INDICATED A BAG WITH IRREGULAR FILM CRACKS OVER THE TOP PORTION OF THE BAG AND INTO THE PORT AREA. NO OTHER ISSUES WERE OBSERVED FROM THE BAG PICTURES. A CAPA HAD PREVIOUSLY BEEN ISSUED TO INVESTIGATE FILM BREAKS OF THIS NATURE. A REVIEW OF THE CAPA INVESTIGATION INDICATED FAILURE MODES OF THIS TYPE HAVE BEEN REPRODUCED BY INTRODUCING AN AIR BUBBLE INSIDE THE BAG PRIOR TO FREEZING. AN AIR BUBBLE COULD RAPIDLY EXPAND DURING THE THAWING PROCESS, RESULTING IN A FILM TEAR. THE EVIDENCE OBSERVED FROM THE PROVIDED PICTURES SUGGESTS THE LIKELY ROOT CAUSE OF THE CRACKED FILM WAS THE EXISTENCE OF AN AIR BUBBLE IN THE BAG PRIOR TO FREEZING. PRECAUTIONS FOR AIR BUBBLES INSIDE THE BAG PRIOR TO FREEZING ARE ADDRESSED IN THE PRODUCT IFU'S.

    Description of Event or Problem · 1

    THE INFORMATION PROVIDED BY THE CUSTOMER INDICATED A BAG CRACKED DURING THE THAWING PROCESS. THE CRACK OCCURRED IN A LABORATORY SETTING AND DID NOT INVOLVE A PATIENT. 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
    919166 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 149037

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR