BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEATER-COOLER SYSTEM 3T

    MDR report key: 6368678 · Received March 1, 2017

    Report

    Report Number
    9611109-2017-00112
    Event Type
    Injury
    Date Received
    March 1, 2017
    Date of Event
    November 20, 2015
    Report Date
    March 1, 2017
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWC
    Removal / Correction Number
    Z-2076/2081-2015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERIAL NUMBER IS UNKNOWN, AS THE FACILITY DOES NOT TRACK WHICH UNIT IS USED FOR A GIVEN PROCEDURE. 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). AS THE SERIAL NUMBER IS UNKNOWN, THE DEVICE MANUFACTURE DATE CANNOT BE DETERMINED. 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). THE REPORTING FACILITY (PRINCE OF WALES PRIVATE HOSPITAL) HAS REPORTED THAT MULTIPLE HEATER-COOLER DEVICES HAVE BEEN FOUND TO BE CONTAMINATED WITH MYCOBACTERIUM CHIMAERA (SEE MEDWATCH REPORTS 9611109-2017-00114, 9611109-2017-00115 AND 9611109-2017-00116 FOR DETAILS ON THE UNITS). THE FACILITY DOES NOT TRACK WHICH UNIT IS USED FOR A GIVEN PROCEDURE, SO IT IS UNKNOWN WHICH OF THESE DEVICES WAS USED DURING THE PATIENT'S PROCEDURE. THE INVESTIGATION IS ON-GOING. 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

    LIVANOVA (B)(4) RECEIVED A REPORT THAT A PATIENT TESTED POSITIVE FOR MYCOBACTERIUM CHIMAERA INFECTION AFTER UNDERGOING AN AORTIC VALVE REPLACEMENT PROCEDURE THAT UTILIZED A HEATER-COOLER SYSTEM 3T.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153252 HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND 16-02-80

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other