BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEATER-COOLER SYSTEM 3T

    MDR report key: 24159244 · Received January 23, 2026

    Report

    Report Number
    9611109-2026-90023
    Event Type
    Malfunction
    Date Received
    January 23, 2026
    Date of Event
    December 26, 2025
    Report Date
    January 23, 2026
    Manufacturer
    LIVANOVA DEUTSCHLAND GMBH
    Product Code
    DWC
    UDI-DI
    04033817901136
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G.5. THE HEATER-COOLER 16-02-95 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 JAPAN. 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 HEATER COOLER SYSTEM 3T DISPLAYED AN ERROR MESSAGE ASSOCIATED TO PUMP NOT STARTING (E05 CODE). THE ISSUE OCCURRED DURING SETUP. THERE IS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222368 HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND GMBH 3-KAMMER HYPO 200V 50/60HZ 04033817901136

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown