BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEATER-COOLER SYSTEM 3T

    MDR report key: 15606188 · Received October 14, 2022

    Report

    Report Number
    9611109-2022-00519
    Event Type
    Injury
    Date Received
    October 14, 2022
    Report Date
    April 17, 2023
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWC
    Removal / Correction Number
    Z-2076/2081-2015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SERIAL NUMBER IS UNKNOWN. THIS INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT IF MADE AVAILABLE. 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. 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). LIVANOVA DEUTSCHLAND MANUFACTURES THE HEATER-COOLER SYSTEM 3T. THE INCIDENT OCCURRED IN FRANCE. THE ARTICLE MENTIONS 85 CASES OF INFECTION WITH NONTUBERCULOUS MYCOBACTERIA ASSOCIATED WITH HEALTHCARE AND AESTHETIC PROCEDURES. ANALYSIS OF THE ARTICLE IS ONGOING TO DETERMINE HOW MANY PATIENT INFECTIONS ARE REPORTED IN RELATION TO CARDIAC SURGERY PROCEDURES AND TO CLARIFY IF THESE EVENTS HAVE ALREADY BEEN CAPTURED IN LIVANOVA COMPLAINTS DATABASE. THE INVOLVEMENT OF THE HEATER COOLER 3T WAS NOT STATED CLEARLY WITHIN THE ARTICLE AND LIVANOVA CONTACTED THE AUTHOR IN ORDER TO CLARIFY IT. NO ANSWER HAS BEEN RECEIVED YET. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. LITERATURE REVIEW.

    Additional Manufacturer Narrative · 0

    H10: ANALYSIS OF THE ARTICLE WAS COMPLETED: THERE IS NEITHER MENTION OF LIVANOVA HEATER COOLER 3T BRAND NAME NOR ITS INVOLVEMENT IN THESE CASES OF MYCOBACTERIUM CHIMAERA INFECTION IN THE ARTICLE. MOREOVER, SEVERAL ATTEMPTS TO CONTACT THE CENTRE, WHICH HAS CARRIED OUT MICROBIOLOGICAL ANALYSIS, WERE DONE WITHOUT RECEIVING ANSWER. BASED ON THE ABOVE, NO EVIDENCE OF LIVANOVA DEVICE INVOLVED ALLEGATION EXISTS.

    Description of Event or Problem · 0

    THROUGH LITERATURE REVIEW LIVANOVA BECAME AWARE OF AN ARTICLE DESCRIBING NONTUBERCULOUS MYCOBACTERIA (NTM) INFECTIONS DURING 2012¿2020 ASSOCIATED WITH HEALTH CARE AND AESTHETIC PROCEDURES IN FRANCE. THE ARTICLE MENTIONS 85 CASES OF INFECTION WITH NONTUBERCULOUS MYCOBACTERIA ASSOCIATED WITH HEALTHCARE AND AESTHETIC PROCEDURES.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1781734 HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND 16-02-80

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other