BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEATER-COOLER SYSTEM

    MDR report key: 23288158 · Received October 15, 2025

    Report

    Report Number
    9611109-2025-90431
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Date of Event
    September 15, 2025
    Report Date
    October 14, 2025
    Manufacturer
    LIVANOVA DEUTSCHLAND GMBH
    Product Code
    DWC
    UDI-DI
    04033817901099
    Removal / Correction Number
    Z-2076/2081-2015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A.1.-A.5. THERE IS NO REPORT OF ANY 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). H.9. LIVANOVA DEUTSCHLAND IMPLEMENTED A FIELD SAFETY NOTICE FOR DISINFECTION AND CLEANING OF HEATER-COOLER DEVICES. THE Z NUMBER IS Z-2076/2081-2015. H11: LIVANOVA DEUTSCHLAND MANUFACTURES THE 3T HEATER COOLER THE USER REQUIRED DEEP DISINFECTION PROCEDURE. 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 A 3T HEATER COOLER RESULTED POSITIVE TO MYCOBACTERIUM CHIMAERA. THERE IS NO REPORT OF ANY PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2596177 HEATER-COOLER SYSTEM CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND GMBH HEATER COOLER 3T 04033817901099

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown