BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEATER-COOLER 3T SYSTEM

    MDR report key: 24304256 · Received February 10, 2026

    Report

    Report Number
    9611109-2026-90039
    Event Type
    Malfunction
    Date Received
    February 10, 2026
    Date of Event
    December 17, 2025
    Report Date
    May 14, 2026
    Manufacturer
    LIVANOVA DEUTSCHLAND GMBH
    Product Code
    DWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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). H.11 LIVANOVA DEUTSCHLAND MANUFACTURES THE HEATER-COOLER SYSTEM 3T. THE INCIDENT OCCURRED IN GERMANY. REPORTEDLY, THE COMPRESSOR IS NOT COOLING CORRECTLY. 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 ABOUT AN HEATER COOLER 3T SYSTEM NOT COOLING PROPERLY. THE ISSUE OCCURRED DURING SETUP. THERE IS NO REPORT OF PATIENT/USER INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309796 HEATER-COOLER 3T SYSTEM CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND GMBH HEATER COOLER 3T

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown