BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEATER-COOLER 3T SYSTEM

    MDR report key: 23879611 · Received December 23, 2025

    Report

    Report Number
    9611109-2025-90628
    Event Type
    Malfunction
    Date Received
    December 23, 2025
    Date of Event
    November 24, 2025
    Report Date
    December 23, 2025
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWC
    UDI-DI
    04033817901099
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    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 3T HEATER COOLER SYSTEM. THE EVENT OCCURED IN (B)(6) INDIA. 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, SHOWING THE ERROR PUMP 1 IN THE PATIENT CIRCUIT WILL NOT START (E05). THE ERROR APPEARS INTERMITTENTLY AFTER REPLACING THE DISTRIBUTION BOARD AND CIRCULATION MOTOR. THERE IS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2477315 HEATER-COOLER 3T SYSTEM CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND HEATER COOLER 3T 04033817901099

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown