BEUDAMED
    FDA Adverse Event Death Summary report: N

    CRD FLEX 3000CC CANISTER WITH VALVE

    MDR report key: 10468687 · Received August 28, 2020

    Report

    Report Number
    1423537-2020-00506
    Event Type
    Death
    Date Received
    August 28, 2020
    Date of Event
    August 9, 2020
    Report Date
    December 23, 2020
    Manufacturer
    TX027 TX-JACKSONVILLE-MCKNIGHT
    Product Code
    GCX
    UDI-DI
    10885380158612
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT IS BEING FILED, SINCE THE RESULTS OF THE INVESTIGATION ARE NOW AVAILABLE. A THOROUGH INVESTIGATION INTO THE INCIDENT REPORTED, HAS BEEN COMPLETED REGARDING THE OUTER CANISTER USED WITH A DISPOSABLE LINER. BASED ON THE INFORMATION OBTAINED FROM THE HEALTHCARE FACILITY IN FRANCE. IT WAS DETERMINED, THAT THE CANISTER WAS NOT PLACED INTO A WALL BRACKET OR ROLL STAND AS STATED, IN THE DIRECTIONS FOR USE. THEREFORE, THE DEVICE FAILED TO WORK AS INTENDED. THE DFU UNDER SETUP STATES, "IF NOT ALREADY IN A MOUNTING BRACKET, PLACE REUSABLE HARD CANISTER INTO A BRACKET ON A ROLL STAND OR WALL MOUNT. DEVICE IS TO BE USED IN VERTICAL ORIENTATION ONLY". CANISTER SHUT OFF AND SUCTION STOPPED SINCE DEVICE WAS USED WITHOUT THE HOLDER TO MAINTAIN VERTICAL POSITION AS REQUIRED. THE PRODUCT WORKED AS DESIGNED. CARDINAL HEALTH¿S MANUFACTURING TEAM WILL BE ADDING AN ORIENTATION ARROW ONTO THE CANISTER, THAT WILL HELP THE END USERS WHO DO NOT NECESSARILY SEE THE INSTRUCTIONS FOR USE (IFU) ON PROPER SETUP OF THE CANISTER, WITH LINER SETUP TO PREVENT IMPROPER SETUP.

    Additional Manufacturer Narrative · 1

    INVESTIGATION INTO THIS REPORTED INCIDENT IS ON-GOING WHILE WE CONTINUE TO GATHER FURTHER DETAILS RELATED TO THE EVENT. A FOLLOW-UP REPORT WILL BE FILED ONCE THE RESULTS HAVE BEEN COMPLETED.

    Description of Event or Problem · 1

    THE SUCTION CANISTER IS USED WITHOUT A STAND KEEPING IT VERTICAL AND CAN BE LYING DOWN OR SHOCKED AT ANY TIME DURING RESUSCITATION. THIS MAY RESULT IN THE SAFETY VALVE BEING CLAMPED ON THE OUTLET AND THEREBY STOPPING THE SUCTION. LACK OF INFORMATION ON THE DEVICE, ON THE RISK OF STOPPING THE VACUUM. THIS TYPE OF EVENT WAS SUSPECTED DURING LOSS OF SUCTION DURING CPR (CARDIOPULMONARY RESUSCITATION) IN EMERGENCIES, HAVING RESULTED IN EIGAS (SERIOUS ADVERSE EVENT RELATED TO TREATMENT) DEATH OF PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    933506 CRD FLEX 3000CC CANISTER WITH VALVE APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED GCX TX027 TX-JACKSONVILLE-MCKNIGHT 65652-631A UNKNOWN 10885380158612

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR Death