BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEATER-COOLER SYSTEM 3T

    MDR report key: 19960088 · Received August 12, 2024

    Report

    Report Number
    9611109-2024-00362
    Event Type
    Death
    Date Received
    August 12, 2024
    Date of Event
    February 22, 2017
    Report Date
    October 28, 2024
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWC
    Removal / Correction Number
    Z-2076/2081-2015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4. THE EVENT IS RELATED TO A LEGAL CASE AND IN ORDER TO COLLECT ADDITIONAL INFORMATION FROM CUSTOMER IS REQUIRING THE INVOLVEMENT OF LEGAL DEPARTMENT. ATTEMPTS WILL BE MADE TO TRY TO RETRIEVE THE SERIAL NUMBER OF THE DEVICE. 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: K220635). 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. H11: LIVANOVA DEUTSCHLAND MANUFACTURES THE HEATER-COOLER SYSTEM 3T. THE INCIDENT OCCURRED IN VICENZA, ITALY. A DHR REVIEW COULD NOT BE PERFORMED SINCE POSSIBLE SERIAL NUMBER INVOLVED WAS NOT PROVIDED. BASED ON CURRENT STATUS OF THE INVESTIGATION THE ALLEGED DEVICE ISSUE WAS NOT CONFIRMED YET. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    H11: THROUGH FOLLOW-UP COMMUNICATION LIVANOVA LEARNED THAT IN 2017, YEAR OF THE INVOLVED SURGERY, FOLLOWING HEATER COOLER 3T DEVICES SERIAL NUMBERS (MODEL 16-02-80) WERE IN USE AT THE HOSPITAL: (B)(6). DEVICE HISTORY RECORD (DHR) REVIEW OF THE ABOVE-MENTIONED SERIAL NUMBERS WAS PERFORMED AND DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. NO DEVICE, BETWEEN THE ONES POSSIBLE INVOLVED AND IN USE AT THE HOSPITAL AT THE TIME OF SURGERY (2017), WAS UPGRADED WITH VACUUM AND SEALING KIT. NO FURTHER INVESTIGATION IS POSSIBLE. SOURCE OF PATIENT CONTAMINATION REMAINS UNKNOWN AND A DIRECT RELATIONSHIP BETWEEN THE REPORTED ADVERSE EVENT AND THE DEVICE COULD NOT BE ESTABLISHED.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGES THROUGH THEIR COUNSEL A MYCOBACTERIUM CHIMAERA INFECTION FOLLOWING A CARDIAC SURGERY (REPLACEMENT OF AORTIC VALVE WITH BIOLOGICAL PROSTHESIS AND REPLACEMENT OF THE ASCENDING AORTA WITH VASCULAR PROSTHESIS) CARRIED OUT ON (B)(6) 2017, IN WHICH A HEATER-COOLER SYSTEM 3T WAS USED. AFTER LONG INFECTION INCUBATION AND SERIOUS SUFFERING, THE PATIENT DIED ON (B)(6) 2023.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1725018 HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND 16-02-80

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Male Death