BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEATER-COOLER SYSTEM 3T

    MDR report key: 17236603 · Received June 30, 2023

    Report

    Report Number
    9611109-2023-00294
    Event Type
    Death
    Date Received
    June 30, 2023
    Date of Event
    January 10, 2012
    Report Date
    February 28, 2024
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWC
    Removal / Correction Number
    Z-2076/2081-2015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: THROUGH FOLLOW UP COMMUNICATION, LIVANOVA LEARNED THAT POSSIBLE INVOLVED DEVICE SERIAL NUMBERS COULD BE THE FOLLOWING: SNS (B)(6) (MANUFACTURED ON 14 MARCH 2007) OR (B)(6) (MANUFACTURED ON 16 MARCH 2007) OR (B)(6) (MANUFACTURED ON 20 SEPTEMBER 2012) (MODEL: 16-02-80). NO OTHER INFORMATION HAS BEEN MADE AVAILABLE FROM THE CUSTOMER. DHR REVIEW OF POSSIBLE INVOLVED DEVICE SERIAL NUMBERS HAS BEEN COMPLETED AND DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. SOURCE OF PATIENT CONTAMINATION REMAINS UNKNOWN AND THE LIVANOVA DEVICE INVOLVEMENT AS WELL. ANYWAY, LIVANOVA ALREADY IMPLEMENTED A STRATEGY TO DECREASE THE PROBABILITY OF BACTERIA GROW IN THE HC DEVICE BY APPLYING MULTIPLE MEASURES IMPLEMENTED OVER THE PAST FEW YEARS THROUGH DEDICATED CAPA AND FIELD ACTION. NO DEVICE, BETWEEN THE ONES POSSIBLE INVOLVED AND IN USE AT THE HOSPITAL AT THE TIME OF SURGERIES ((B)(6) 2012), WAS UPGRADED WITH VACUUM AND SEALING KIT. THE RISK IS IN THE ACCEPTABLE REGION. NO SPECIFIC ACTION WAS CURRENTLY DEEMED NECESSARY. LIVANOVA WILL KEEP MONITORING THE MARKET.

    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: 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 DUBLIN, IRELAND. 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.

    Description of Event or Problem · 0

    SEE INITIAL REPORT

    Description of Event or Problem · 0

    LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A MALE PATIENT UNDERGOING A MITRAL VALVE REPLACEMENT AND CARDIOPULMONARY BYPASS ON (B)(6) 2012 WAS FOUND TO BE INFECTED BY MYCOBACTERIUM CHIMAERA AND DIED ON (B)(6) 2013 FOR AN ENDOCARDITIS. HEATER-COOLER 3T WAS USED IN THIS SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    855319 HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND 16-02-80

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Death