BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEATER COOLER 3T SYSTEM

    MDR report key: 23706244 · Received December 3, 2025

    Report

    Report Number
    9611109-2025-90571
    Event Type
    Malfunction
    Date Received
    December 3, 2025
    Date of Event
    November 3, 2025
    Report Date
    June 10, 2026
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWC
    UDI-DI
    04033817901099
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    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). H11 LIVANOVA DEUTSCHLAND MANUFACTURES THE HEATER COOLER 3T SYSTEM, THE EVENT OCCURRED IN UNITED KINGDOM. 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 REGARDING A HEATER COOLER 3T SYSTEM THAT WAS INTERMITTENTLY LOSING POWER WHILE ARCING NOISES WERE HEARD FROM THE PLUG. THE ISSUE OCCURRED DURING SERVICE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2857639 HEATER COOLER 3T SYSTEM CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND HEATER COOLER 3T 04033817901099

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown