BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3T HEATER/COOLER

    MDR report key: 24637363 · Received March 19, 2026

    Report

    Report Number
    9611109-2026-90100
    Event Type
    Malfunction
    Date Received
    March 19, 2026
    Date of Event
    February 17, 2026
    Report Date
    March 19, 2026
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWC
    UDI-DI
    04033817901099
    PMA / PMN Number
    K220635
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 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 3T HEATER/COOLER WHOSE PATIENT PUMP COULD NOT RETRIEVE PROPER FLOW, AND ERROR MESSAGE E16 WAS CONSEQUENTLY DISPLAYED. THE EVENT OCCURRED DURING PROCEDURE. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698695 3T HEATER/COOLER CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND HEATER COOLER 3T 04033817901099

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown