BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEATER COOLER 3T SYSTEM

    MDR report key: 24894836 · Received April 16, 2026

    Report

    Report Number
    9611109-2026-90150
    Event Type
    Malfunction
    Date Received
    April 16, 2026
    Date of Event
    March 18, 2026
    Report Date
    April 16, 2026
    Manufacturer
    LIVANOVA DEUTSCHLAND
    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 THERE WAS NO PATIENT INVOLVEMENT 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 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 THAT THE HEATER COOLER 3T SYSTEM DISPLAYED ERROR CODES RELATED TO PATIENT PUMP FUNCTION (E05 AND E07). REPORTEDLY, THE PUMP STOPPED WORKING. THE EVENT OCCURRED DURING ROUTINE MAINTENANCE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518488 HEATER COOLER 3T SYSTEM CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND 3-KAMMER HYPO 200V 50/60HZ 04033817901138

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown