BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEATER-COOLER 3T SYSTEM

    MDR report key: 23594609 · Received November 19, 2025

    Report

    Report Number
    9611109-2025-90532
    Event Type
    Malfunction
    Date Received
    November 19, 2025
    Date of Event
    October 16, 2025
    Report Date
    November 19, 2025
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWC
    PMA / PMN Number
    N.A.
    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. 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 CHIMERA BACTERIAL CONTAMINATION. THERE IS NO REPORT OF ANY PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2363240 HEATER-COOLER 3T SYSTEM CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND HEATER COOLER 3T

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown