BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEATER-COOLER SYSTEM 3T

    MDR report key: 17297911 · Received July 11, 2023

    Report

    Report Number
    9611109-2023-00315
    Event Type
    Death
    Date Received
    July 11, 2023
    Date of Event
    September 10, 2012
    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

    H10: THROUGH FOLLOW-UP COMMUNICATION WITH CUSTOMER, IT WAS LEARNED THAT 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. NO OTHER 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 AT THE TIME OF THE SURGERY (2012). 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.

    Additional Manufacturer Narrative · 0

    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 (B)(6). 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.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGES THROUGH THEIR COUNSEL A MYCOBACTERIUM CHIMAERA INFECTION. BASED ON CURRENT STATUS OF THE INVESTIGATION THE ALLEGED DEVICE ISSUE WAS YET NOT CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2147563 HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND 16-02-80

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death| O