BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    30 -70ML CELL FREEZE CRYOGENIC STORAGE CONTAINER

    MDR report key: 8040144 · Received November 5, 2018

    Report

    Report Number
    1066733-2018-00018
    Event Type
    Malfunction
    Date Received
    November 5, 2018
    Date of Event
    September 12, 2018
    Report Date
    November 5, 2018
    Manufacturer
    CHARTER MEDICAL, LTD.
    Product Code
    LPZ
    PMA / PMN Number
    BK1000049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CF-250 DEVICE HAS TWO SPIKE PORT COMPONENTS. THE SPIKE PORT COMPONENT CONTAINS A SEPTUM MEMBRANE IN THE INTERIOR TUBE. THE CF-250 IS 100% LEAK TESTED DURING PRODUCTION. THE RETURNED BAG WAS VISUALLY INSPECTED; BOTH SPIKE PORT COMPONENTS OF THE BAG CONTAINED SPIKE COMPONENTS. THE RETURNED BAG HAD AN AREA OF INTEREST IDENTIFIED ON ONE OF THE SPIKE PORT COMPONENTS OF THE BAG. TWO OBSERVATIONS WERE NOTED: A TEAR/HOLE WAS VERIFIED ON ONE OF THE SPIKE PORTS. THE HOLE OCCURRED IN THE SIDE OF THE SPIKE PORT TUBE, BELOW THE SEPTUM. A HOLE AT THIS LOCATION WOULD HAVE BEEN DETECTED UPON FILLING IF IT EXISTED AT THAT TIME (I.E. BEFORE A SPIKE WOULD HAVE BEEN INSERTED INTO THE SPIKE PORT). THE HOLE WAS REPORTED AFTER THE BAG HAD BEEN FROZEN AND THAWED. ADDITIONALLY, A HOLE IN THIS LOCATION WOULD LIKELY BE DETECTED DURING PRODUCTION LEAK TEST IF IT EXISTED AT THAT TIME. THE REMNANTS OF THE SPIKE PORT SEPTUM MEMBRANE WERE OBSERVED INSIDE THE BAG. THIS OBSERVATION IS LIKELY AN INDICATION OF EXCESSIVE FORCE OR INCORRECT USER TECHNIQUE DURING THE SPIKING PROCESS. THE LOCATION AND NATURE OF THE HOLE IN THE SPIKE PORT COMPONENT, ALONG WITH THE PROCESS STEP (AFTER THAWING AND HANGING THE BAG) WHEN THE LEAK WAS DETECTED, SUGGESTS USER EXCESSIVE FORCE OR SPIKING TECHNIQUE LIKELY CONTRIBUTED TO THE HOLE ON THE RETURNED SAMPLE.

    Description of Event or Problem · 1

    A LEAK, FROM THE PORT COMPONENT OF A SINGLE CF-250 PRODUCT WAS REPORTED BY THE USER FACILITY. THE BAG WAS THAWED FOR INFUSION AND HUNG. A HOLE WAS OBSERVED IN THE PORT COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    876569 30 -70ML CELL FREEZE CRYOGENIC STORAGE CONTAINER 30 -70ML CELL FREEZE CRYOGENIC STORAGE CONTAINER LPZ CHARTER MEDICAL, LTD. CF-250 145979

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR