BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEATER-COOLER SYSTEM 3T

    MDR report key: 6368704 · Received March 1, 2017

    Report

    Report Number
    9611109-2017-00113
    Event Type
    Injury
    Date Received
    March 1, 2017
    Date of Event
    February 9, 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 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). (B)(4) IMPLEMENTED A FIELD SAFETY NOTICE FOR DISINFECTION AND CLEANING OF (B)(4) HEATER-COOLER DEVICES. THE Z NUMBER IS Z-2076/2081-2015. (B)(4) MANUFACTURES THE HEATER-COOLER SYSTEM 3T. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS BEING FILED ON BEHALF OF (B)(4). THE REPORTING FACILITY ((B)(6) 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

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152316 HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND 16-02-80

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other