BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEATER-COOLER SYSTEM 3T

    MDR report key: 17753887 · Received September 15, 2023

    Report

    Report Number
    9611109-2023-00441
    Event Type
    Injury
    Date Received
    September 15, 2023
    Report Date
    July 15, 2024
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWC
    Removal / Correction Number
    Z-2076/2081-2015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A.1.-A.5. PATIENT INFORMATION WAS NOT PROVIDED. D.4. SERIAL NUMBER IS UNKNOWN. THIS INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT IF MADE AVAILABLE. H.4. AS THE SERIAL NUMBER IS UNKNOWN, THE DEVICE MANUFACTURE DATE COULD NOT BE DETERMINED. THIS INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT IF MADE AVAILABLE. 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: K191402). H.9. LIVANOVA DEUTSCHLAND IMPLEMENTED A FIELD SAFETY NOTICE FOR DISINFECTION AND CLEANING OF HEATER-COOLER DEVICES. THE Z NUMBER IS Z-2076/2081-2015. H10: LIVANOVA DEUTSCHLAND MANUFACTURES THE HEATER-COOLER SYSTEM 3T. THE INCIDENT OCCURRED IN ZWOLLE, NETHERLANDS. LIVANOVA INITIATED AN INVESTIGATION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    THROUGH FOLLOW UP, LIVANOVA WAS INFORMED THAT THE PATIENT IS REPORTING HEARING PROBLEMS THAT THE PATIENT SUFFERED ALLEGEDLY DUE TO MEDICATION THAT WAS USED IN RELATION TO THE BACTERIAL INFECTION (MYCOBACTERIUM CHIMAERA) AND SUBSEQUENT PROBLEMS WITH ONE OF MORE HEART VALVES. HOWEVER, NO DIRECT CAUSAL LINK BETWEEN THE USE OF THE HEATER COOLER DURING A MEDICAL OPERATION IN 2013 AND THE OCCURRENCE OF THE BACTERIAL INFECTION WHICH WAS DISCOVERED IN 2022 CANNOT BE ESTABLISHED. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    H11: NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE PERFORMED SINCE POSSIBLE SERIAL NUMBER INVOLVED WAS NOT PROVIDED. INVOLVED DEVICE SERIAL NUMBER REMAINED UNKNOWN BUT WAS NOT EQUIPPED WITH VACUUM AND SEALING KIT SINCE UPGRADE ACTIVITY STARTED IN 2017 AND THE SURGERY WAS PERFORMED IN 2013. SOURCE OF PATIENT CONTAMINATION REMAINS UNKNOWN AND THE LIVANOVA DEVICE INVOLVEMENT AS WELL.

    Description of Event or Problem · 0

    LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT, AT THE END OF 2022, A PATIENT BECAME ILL DUE TO A BACTERIA ON THE HEART VALVE. AFTER A CULTURE OF BACTERIA, IT TURNED OUT TO BE THE MYCOBACTERIUM CHIMAERA. THIS PATIENT UNDERWENT HEART SURGERY IN 2013, USING THE HEATER-COOLER SYSTEM 3T. THE PATIENT IS NOW DOING BETTER. HOWEVER, DUE TO TREATMENT OF THE BACTERIA, THE PATIENT IS PERMANENTLY HEARING IMPAIRED ON ONE SIDE.

    Description of Event or Problem · 0

    SEE INITIAL REPORT

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303998 HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND 16-02-80

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other