BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEATER COOLER 3T SYSTEM

    MDR report key: 24797806 · Received April 7, 2026

    Report

    Report Number
    9611109-2026-90135
    Event Type
    Malfunction
    Date Received
    April 7, 2026
    Date of Event
    March 9, 2026
    Report Date
    April 7, 2026
    Manufacturer
    LIVANOVA DEUSTCHLAND
    Product Code
    DWC
    UDI-DI
    04033817901138
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A1-A5: PATIENT INFORMATION WAS NOT PROVIDED. G.5: THE HEATER-COOLER 16-02-95 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 EVENT OCCURRED IN JAPAN. 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 OF A SIGNIFICANT LEAKAGE WHEN REMOVING THE TUBING FROM THE CARDIOPLEGIA-SIDE CONNECTION OF A HEATER-COOLER 3T SYSTEM. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265086 HEATER COOLER 3T SYSTEM CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUSTCHLAND 3-KAMMER HYPO 200V 50/60HZ 04033817901138

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown