BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEATER-COOLER SYSTEM

    MDR report key: 21803409 · Received April 9, 2025

    Report

    Report Number
    9611109-2025-90049
    Event Type
    Death
    Date Received
    April 9, 2025
    Date of Event
    March 10, 2025
    Report Date
    May 9, 2025
    Manufacturer
    LIVANOVA DEUTSCHLAND GMBH
    Product Code
    DTZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    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 SYSTEM 3T. THE 3T HEATER COOLER UNIT IS SIMPLY INVOLVED IN THE WHOLE PROCESS. THE USERS DISINFECT THE TWO BLACK GRILLES BY REGULAR CLEANING AS PER IFU REQUIREMENT. SAMPLES WERE TAKEN FROM THE GRID OF THE THERMAL CEC GENERATOR N° 16S30285: THE RESULT WAS NEGATIVE FOR TRICHOSPORON BUT OTHER SPECIES OF FUNGUS WERE FOUND. THE HC3TS ARE NORMALLY CLEANED EVERY WEEK. ACCORDING TO CUSTOMER, 3T HEATER COOLER UNIT, AS WELL AS EVERYTHING ELSE IN THE OPERATING ROOM, CONTRIBUTED TO THE CAUSE OF BOTH DEATHS. THE CUSTOMER ASKS TO STATE MORE CLEARLY THE MAINTENANCE TO REMOVE THE DUST AND A BIOCLEANING ACTION TO FIGHT AGAINST THE DUST (KNOWING THAT IT IS DUST FROM THE OPERATING FIELD). FROM A PRELIMINARY CLINICAL INVESTIGATION WITH LIVANOVA MEDICAL TEAM IT IS POSSIBLE TO STATE THAT THE FUNGUS MENTIONED BY THE CUSTOMER IN THE EVENT DOES NOT GROW IN DUST ACCUMULATIONS. ITS GROWTH ACTUALLY OCCURS INSTEAD IN A HUMID ENVIRONMENT. THEREFORE, THE INVESTIGATION IS ON-GOING TO VERIFY WHETHER THE ACCUMULATED DUST CAN BE A CONTRIBUTOR FACTOR OF THE EVENT OR NOT. IN ADDITION, FOLLOW-UP COMMUNICATION HAS BEEN STARTED WITH THE CUSTOMER TO ASK IF MICROBIAL TEST RESULT ON DUST HAVE BEEN CARRIED OUT AND IF RESULTS ARE AVAILABLE. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    ON MARCH 10, 2025, THE CUSTOMER REPORTED TO LIVANOVA THREE CASES OF SURGICAL INFECTION WITH FUNGUS TRICHOSPORON AUSTROAMERICANUM. BASED ON INFORMATION PROVIDED, TWO DEATHS HAD ALREADY OCCURRED AT THE HOSPITAL SINCE (B)(6) 2024 (THESE EVENTS WERE NOT REPORTED TO LIVANOVA AT THE TIME), WHILE THE THIRD DEATH WAS REPORTED TO HAVE OCCURRED ON (B)(6) 2025. IN THE CONTEXT OF THE THIRD INFECTION, THE CUSTOMER ALLEGED ABOUT FUNGUS TRICHOSPORON AUSTROAMERICANUM GROWING IN DUST ENVIRONMENT AND THAT THIS MIGHT HAVE ORIGINATED FROM ANYTHING PRESENT IN THE OPERATING ROOM (ANY SURFACE AND/OR EQUIPMENT USED INCLUDING ALSO THE HEATER COOLER DEVICE). THROUGH FOLLOW UP COMMUNICATION WITH CUSTOMER LIVANOVA BECAME AWARE THAT THE HEATER COOLER 3T (B)(6) WAS USED FOR THE MENTIONED SURGERIES AND THAT IT IS NOT THE CAUSE OF THE THREE SURGICAL INFECTIONS. THIS WAS CONFIRMED BY THE FACT THAT SAMPLES OF DUST WERE TAKEN FROM THE GRID OF THE HEATER COOLER 3T (B)(6) AND ANALYZED. THE TEST RESULTED NEGATIVE TO FUNGUS TRICHOSPORON AUSTROAMERICANUM EXCLUDING THE HEATER COOLER DEVICE FROM BEING THE CAUSE OF THE SURGICAL INFECTIONS. CURRENTLY LIVANOVA IS NOT AWARE OF ANY OTHER ACTION UNDERTAKEN BY THE CUSTOMER ON THE DEVICE. IN CONCLUSION, BASED ON INVESTIGATION RESULTS, ANY RELATIONSHIP BETWEEN THE REPORTED INFECTION AND THE HEATER COOLER DEVICE IS EXCLUDED. NO SPECIFIC ACTION WAS CURRENTLY DEEMED NECESSARY, LIVANOVA MAINTAINS AND DOCUMENTS PERIODIC CUSTOMER EVENTS MONITORING PROCESS IN ORDER TO EVALUATE ACTIONS FOR PRODUCTS IMPROVEMENT.

    Description of Event or Problem · 0

    LIVANOVA DEUTSCHLAND RECEIVED A REPORT RELATED TO A DUST INFECTION OF TRICHOSPORON AUSTROAMERICANUM IN AN OPERATING ROOM THROUGH A HEATER-COOLER SYSTEM 3T DEVICE. FOLLOWING A 3RD CASE OF TRICHOSPORON AUSTROAMERICANUM SURGICAL SITE INFECTION, THAT HAS ALREADY LED TO TWO DEATHS IN THE HOSPITAL SINCE (B)(6) 2024, CUSTOMER MOVED TO OPERATING BLOCK 6 ON (B)(6). THE CUSTOMER THEN OBSERVED DUST BUILD-UP IN THE 3T DEVICE GRIDS IN BLOCK 6, ASKING LIVANOVA TO CARRY OUT A BIOCLEANING OF THE GRIDS FOR THIS DEVICE AND FOR THE ENTIRE FLEET URGENTLY.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1666138 HEATER-COOLER SYSTEM CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DTZ LIVANOVA DEUTSCHLAND GMBH HEATER COOLER 3T (230 VOLT)

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death