BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEATER-COOLER SYSTEM 3T

    MDR report key: 7094737 · Received December 7, 2017

    Report

    Report Number
    9611109-2017-00965
    Event Type
    Injury
    Date Received
    December 7, 2017
    Report Date
    December 6, 2017
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWC
    Removal / Correction Number
    Z-2076/2081-2015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    E INITIAL REPORTER INFORMATION WAS NOT PROVIDED. THIS INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT IF MADE AVAILABLE. PMA 510(K): 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: K052601). RECALL NUMBER: 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). IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. DEVICE NOT RETURNED..

    Description of Event or Problem · 1

    LIVANOVA (B)(4) RECEIVED A REPORT THAT A PATIENT WHICH UNDERWENT A MITRAL VALVE REPAIR AND TRICUSPID ANNULOPLASTY IN 2016 WAS INFECTED WITH MYCOBACTERIUM CHIMAERA. IT WAS REPORTED THAT A HEATER-COOLER SYSTEM WAS USED DURING THAT PERIOD OF TIME AND THE DEVICE WAS FOUND TO BE CONTAMINATED WITH MYCOBACTERIUM CHIMAERA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    877727 HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND 16-02-80

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| O