BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEATER-COOLER SYSTEM 3T

    MDR report key: 21764835 · Received April 3, 2025

    Report

    Report Number
    9611109-2025-90028
    Event Type
    Malfunction
    Date Received
    April 3, 2025
    Date of Event
    March 4, 2025
    Report Date
    April 2, 2025
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWC
    UDI-DI
    04033817901099
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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 SYSTEM 3T. THE INCIDENT OCCURRED IN THEALE, UNITED KINGDOM. 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 DEUTSCHLAND RECEIVED A REPORT THAT A HEATER-COOLER SYSTEM 3T WAS NOT COOLING ON THE PATIENT CIRCUIT. THE ISSUE OCCURRED WHEN THE MACHINE WAS IN SERVICE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613993 HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND HEATER COOLER 3T (230 VOLT) 04033817901099

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown