BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEATER-COOLER SYSTEM

    MDR report key: 23072809 · Received September 17, 2025

    Report

    Report Number
    9611109-2025-90361
    Event Type
    Death
    Date Received
    September 17, 2025
    Date of Event
    August 7, 2025
    Report Date
    September 17, 2025
    Manufacturer
    LIVANOVA DEUTSCHLAND GMBH
    Product Code
    DWC
    UDI-DI
    04033817901099
    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 A LIVANOVA FIELD SERVICE ENGINEER WAS DISPATCHED THE CUSTOMER AND INSPECTED THE DEVICE. THE DISTRIBUTION BOARD AND PATIENT PUMP 2 WILL LIKELY BE REPLACED TO SOLVE THE ISSUE. 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 3T HEATER COOLER DISPLAYED AN ALARM MEANING PUMP 1 IS BLOCKED (TOO SLOW, E07) DURING DISINFECTION. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2553201 HEATER-COOLER SYSTEM CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND GMBH HEATER COOLER 3T 04033817901099

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown