BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEATER COOLER 3T

    MDR report key: 17257035 · Received July 5, 2023

    Report

    Report Number
    9611109-2023-00300
    Event Type
    Death
    Date Received
    July 5, 2023
    Date of Event
    July 31, 2014
    Report Date
    May 6, 2024
    Manufacturer
    LIVANOVA DEUTSCHLAND GMBH
    Product Code
    DWC
    Removal / Correction Number
    Z-2076/2081-2015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    G.5. THE HEATER-COOLER 16-02-80 IS NOT DISTRIBUTED IN THE USA, BUT 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 ITALY. LIVANOVA INITIATED AN INVESTIGATION. THIS EVENT WAS BROUGHT TO LIVANOVA¿S NOTICE BY A LAWSUIT BEING FILED, AND THE POSSIBILITY TO SPEAK WITH THE PERSON SUING US IS LIMITED BY THE RULES OF LITIGATION. HOWEVER, LIVANOVA IS WORKING IN COLLABORATION WITH ITS LEGAL DEPARTMENT TO OBTAIN ANY RELEVANT INFORMATION FROM THE COMPLAINANT. LIVANOVA WILL TIMELY SHARE WITH THE COMPETENT AUTHORITY IN A FOLLOW-UP REPORT ANY RELEVANT ADDITIONAL INFORMATION RECEIVED. LIVANOVA WILL TIMELY SHARE WITH THE COMPETENT AUTHORITY IN A FOLLOW-UP REPORT ANY RELEVANT ADDITIONAL INFORMATION RECEIVED.

    Additional Manufacturer Narrative · 0

    H10: THROUGH FOLLOW-UP COMMUNICATION WITH CUSTOMER, IT WAS LEARNED THAT SURGERY WAS PERFORMED ON (B)(6) 2014 AND PATIENT DIED, AS A RESULT OF THE INFECTION. THE ALLEGATION IS THAT THE MYCOBACTERIA CHIMAERA DERIVED FROM THE HEATER-COOLER SYSTEM 3T USED DURING THE HEART VALVE SURGERY. SOURCE OF MYCOBACTERIA CHIMAERA HAS NEVER BEEN DETERMINED. FURTHERMORE, IT WAS LEARNED THAT POSSIBLE DEVICE SERIAL NUMBERS INVOLVED DURING THE SURGERIES WERE (B)(6) (MODEL 16-02-80). FOR (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 (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 HOSPITAL AT THE TIME OF SURGERY (2014) 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 RECEIVED REPORT THAT A PATIENT INFECTION BY M. CHIMAERA. ON (B)(6) 2021, LIVANOVA RECEIVED NOTICE OF A PRELIMINARY TECHNICAL APPRAISAL PROCEEDINGS ("ATP") INITIATED BEFORE THE COURT OF VICENZA BY THE HEIRS OF A PATIENT AGAINST THE (B)(6)CLINICO S (NOW ISTITUTO (B)(6)) IN MILAN, AND AGAINST THE HOSPITAL OF(B)(6)(FOR LATE DIAGNOSIS). THE IST. ORTOPEDICO GALEAZZI HAS REQUESTED THAT LIVANOVA DEUTSCHLAND IS CALLED INTO THE CASE, ALLEGING THEIR RESPONSIBILITY AS MANUFACTURER OF THE 3T DEVICE, USED IN THE SURGERY.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1930321 HEATER COOLER 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND GMBH 16-02-80

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death