BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEATER-COOLER SYSTEM 3T

    MDR report key: 17181606 · Received June 22, 2023

    Report

    Report Number
    9611109-2023-00281
    Event Type
    Death
    Date Received
    June 22, 2023
    Date of Event
    January 16, 2014
    Report Date
    May 6, 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

    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 MILAN AND VARESE, ITALY. LIVANOVA INITIATED AN INVESTIGATION AND IS FOLLOWING UP WITH THE CUSTOMER. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    H10: THROUGH FOLLOW-UP COMMUNICATION LIVANOVA LEARNED THAT POSSIBLE DEVICE SERIAL NUMBERS INVOLVED DURING THE SURGERIES WERE (B)(6) (MODEL 16-02-80). THE ALLEGATION IS THAT THE MYCOBACTERIUM CHIMAERA INFECTION DERIVED FROM THE HEATER COOLER 3T DEVICE USED DURING THE OPERATION. SOURCE OF MYCOBACTERIUM CHIMAERA HAS NEVER BEEN DETERMINED. FOR SN (B)(6) DEVICE HISTORY RECORD (DHR) REVIEW IS UNHELPFUL SINCE IT WAS MANUFACTURED IN 2006, WHILE ALLEGED SURGERY ISSUE OCCURRED IN 2014 AND CONTRIBUTION OF POSSIBLE NATIVE DEFECTS CAN BE EXPECTED DURING FIRST USAGES. FOR SN (B)(6) A REVIEW OF THE DEVICE HISTORY RECORD (DHR) 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 HOSPITALS AT THE TIME OF SURGERIES (2014 AND 2015), WAS EQUIPPED 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

    LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A MALE PATIENT THAT UNDERGONE A FIRST HEART SURGERY ON (B)(6) 2014 AT (B)(6) IN MILAN AND A SECOND ONE ON (B)(6) 2015 AT (B)(6) IN VARESE WAS FOUND TO BE INFECTED BY MYCOBACTERIUM CHIMAERA ON (B)(6) 2015. HE DIED PRESUMABLY ON (B)(6) 2020.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1217383 HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND 16-02-80

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Death