BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEATER-COOLER SYSTEM 3T

    MDR report key: 6372454 · Received March 2, 2017

    Report

    Report Number
    9611109-2017-00121
    Event Type
    Malfunction
    Date Received
    March 2, 2017
    Date of Event
    January 31, 2017
    Report Date
    March 2, 2017
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWC
    Removal / Correction Number
    Z-2076/2081-2015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO KNOWN PATIENT INVOLVEMENT. PMA 510(K): THE HEATER-COOLER DEVICE 16-02-80 IS NOT DISTRIBUTED IN THE USA. HOWEVER, IT IS SIMILAR TO THE HEATER-COOLER DEVICE 16-02-85, WHICH IS DISTRIBUTED IN THE USA (510(K) NUMBER: K052601). RECALL NUMBER: LIVANOVA IMPLEMENTED A FIELD SAFETY NOTICE FOR DISINFECTION AND CLEANING OF LIVANOVA 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). THIS MEDWATCH REPORT IS BEING FILED ON BEHALF OF LIVANOVA (B)(4). THROUGH FOLLOW-UP COMMUNICATION WITH THE CUSTOMER, LIVANOVA (B)(4) CONFIRMED THAT THERE ARE NO KNOWN PATIENT INFECTIONS RELATED TO THE REPORTED CONTAMINATION. THE FACILITY HAS STOPPED THE USE OF THE INVOLVED DEVICE AND HAS REQUESTED RETURN TO LIVANOVA DEUTSCHLAND FOR DEEP DISINFECTION. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    LIVANOVA (B)(4) RECEIVED A REPORT THAT MYCOBACTERIUM CHIMAERA WAS CULTURED FROM WATER SAMPLES TAKEN FROM THE HEATER-COOLER SYSTEM 3T DURING MAINTENANCE. THERE IS NO KNOWN PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155265 HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND 16-02-80

    Patients

    Seq Age Sex Outcome Treatment
    1