BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEATER-COOLER SYSTEM 3T

    MDR report key: 23268818 · Received October 10, 2025

    Report

    Report Number
    9611109-2025-90423
    Event Type
    Malfunction
    Date Received
    October 10, 2025
    Date of Event
    September 11, 2025
    Report Date
    October 10, 2025
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A.1.-A.5. THERE WAS NO PATIENT INVOLVEMENT. 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 INCIDENT OCCURRED IN FRANCE. 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 RECEIVED REPORT THAT A HEATER COOLER SYSTEM 3T DISPLAYED ERROR CODE E17, PUMP 2 USES TOO MUCH POWER. THE ISSUE OCCURRED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2280597 HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND HEATER COOLER 3T

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown