BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEATER-COOLER SYSTEM 3T

    MDR report key: 10648547 · Received October 8, 2020

    Report

    Report Number
    9611109-2020-00563
    Event Type
    Injury
    Date Received
    October 8, 2020
    Report Date
    October 5, 2020
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWC
    Removal / Correction Number
    Z-2076/2081-2015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO KNOWN PATIENT INVOLVEMENT. 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 (B)(4) IMPLEMENTED A FIELD SAFETY NOTICE FOR DISINFECTION AND CLEANING OF HEATER-COOLER DEVICES. THE Z NUMBER IS Z-2076/2081-2015. LIVANOVA (B)(4) MANUFACTURES THE HEATER-COOLER SYSTEM 3T . THE INCIDENT OCCURRED IN (B)(6). LIVANOVA WILL ATTEMPT TO RETRIEVE ADDITIONAL DETAILS. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THROUGH LITERATURE REVIEW LIVANOVA BECAME AWARE OF THREE (3) PATIENTS INFECTED WITH MYCOBACTERIUM CHIMAERA IN (B)(6). THE THREE PATIENTS DIAGNOSED IN 2019 WERE DETECTED BY PASSIVE CASE FINDING DUE TO THE CLINICAL AWARENESS OF THEIR CLINICIANS. WITHIN THE ARTICLE IT IS STATED THAT THESE EVENTS HAVE BEEN REPORTED TO THE HEALTH AUTHORITIES. THE HOSPITAL/HOSPITALS WERE THE SURGERIES TOOK PLACE AND THE DATE OF THE SURGERIES ARE UNKNOWN, AS WELL AS THE SERIAL NUMBER OF THE HEATER-COOLER USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1114519 HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND 16-02-80

    Patients

    Seq Age Sex Outcome Treatment
    1