BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEATER-COOLER 3T SYSTEM

    MDR report key: 24112978 · Received January 20, 2026

    Report

    Report Number
    9611109-2026-90017
    Event Type
    Malfunction
    Date Received
    January 20, 2026
    Date of Event
    December 22, 2025
    Report Date
    January 20, 2026
    Manufacturer
    LIVANOVA DEUTSCHLAND GMBH
    Product Code
    DWC
    UDI-DI
    04033817901099
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A.1.-A.5. PATIENT INFORMATION WAS NOT PROVIDED. 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 EVENT OCCURED IN IRELAND. LIVANOVA HAS 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 REGARDING A HEATER COOLER 3T SYSTEM NOT COOLING PROPERLY ON PATIENT SIDE. THE ISSUE OCCURRED DURING PROCEDURE. THERE IS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176654 HEATER-COOLER 3T SYSTEM CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND GMBH HEATER COOLER 3T 04033817901099

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown