BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEATER-COOLER SYSTEM 3T

    MDR report key: 17000649 · Received May 25, 2023

    Report

    Report Number
    1718850-2023-01004
    Event Type
    Death
    Date Received
    May 25, 2023
    Report Date
    May 19, 2023
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWC
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A.1.-A.5. PATIENT INFORMATION WAS NOT PROVIDED H.10: LIVANOVA DEUTSCHLAND IMPLEMENTED A FIELD SAFETY NOTICE FOR DISINFECTION AND CLEANING OF HEATER-COOLER DEVICES. THE Z NUMBER IS Z-2076/2081-2015. LIVANOVA DEUTSCHLAND MANUFACTURES THE HEATER-COOLER SYSTEM 3T. THE INCIDENT OCCURRED IN THE UNITES STATES LIVANOVA INITIATED AN INVESTIGATION. THE PRESENT IMPORTER MEDWATCH WAS INITIALLY SUBMITTED ON 19MAY2023 AND RESUBMITTED ON 25MAY2023.

    Description of Event or Problem · 0

    LIVANOVA RECEIVED REPORT OF AN ALLEGED M. CHIMAERA INFECTION. ON (B)(6) 2015, PATIENT WAS OPERATED FOR ELECTIVE VALVE REPLACEMENT (OPEN HEART SURGERY) AND DISCHARGED ON (B)(6) 2015. ON (B)(6) 2022, RESULT OF PATIENT¿S SAMPLE TAKEN ON (B)(6) 2022 RESULTED POSITIVE TO MYCOBACTERIUM AVIUM COMPLEX. ON (B)(6) 202S, PATIENT ADMITTED AT (B)(6) FOR ALTERED MENTAL STATUS AND FEVER. CULTURES WERE REPEATED AND CONFIRMED INFECTION TO MYCOBACTERIUM CHIMAERA. ON (B)(6) 2022, PATIENT PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741380 HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND 16-02-82

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Death