BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEATER-COOLER 3T SYSTEM

    MDR report key: 24697332 · Received March 26, 2026

    Report

    Report Number
    9611109-2026-90111
    Event Type
    Malfunction
    Date Received
    March 26, 2026
    Date of Event
    February 27, 2026
    Report Date
    March 26, 2026
    Manufacturer
    LIVANOVA DEUTSCHLAND GMBH
    Product Code
    DWC
    UDI-DI
    04033817901099
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A.1.-A.5. PATIENT INFORMATION WAS NOT PROVIDED. 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 ITALY. LIVANOVA HAS 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 A HEATER-COOLER SYSTEM 3T WAS NOISY AND TRIPPED THE MAINS POWER SUPPLY DURING CLEANING ACTIVITY. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762266 HEATER-COOLER 3T SYSTEM CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND GMBH HEATER COOLER 3T 04033817901099

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown