BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEATER-COOLER SYSTEM 3T

    MDR report key: 23269752 · Received October 10, 2025

    Report

    Report Number
    9611109-2025-90426
    Event Type
    Malfunction
    Date Received
    October 10, 2025
    Date of Event
    September 12, 2025
    Report Date
    October 10, 2025
    Manufacturer
    LIVANOVA DEUTSCHLAND GMBH
    Product Code
    DWC
    PMA / PMN Number
    K082344
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A.1.-A.5. THERE WAS NO PATIENT INVOLVEMENT. G.5. THE HEATER-COOLER 16-02-80 IS NOT DISTRIBUTED IN THE USA, AND IT IS SIMILAR TO HEATER-COOLER 16-02-85, WHICH IS DISTRIBUTED IN THE USA (510(K) NUMBER: K220635). H11: LIVANOVA DEUTSCHLAND MANUFACTURES THE HEATER-COOLER 3T SYSTEM. THE INCIDENT OCCURRED IN GERMANY. LIVANOVA INITIATED AN INVESTIGATION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT THE 3T HEATER COOLER DEVICE SHOWED THE ERROR MESSAGE EARTH FAULT, DURING SETUP, AS SOON AS IT WAS PLUGGED IN. THERE IS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2576445 HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND GMBH HEATER COOLER 3T

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown