BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEATER-COOLER SYSTEM 3T

    MDR report key: 6427960 · Received March 23, 2017

    Report

    Report Number
    9611109-2017-00208
    Event Type
    Injury
    Date Received
    March 23, 2017
    Report Date
    March 23, 2017
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT DATE WAS NOT PROVIDED. THIS INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT IF MADE AVAILABLE. 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) MANUFACTURES THE HEATER-COOLER SYSTEM 3T. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS BEING FILED ON BEHALF OF (B)(4). THE HOSPITAL HAS REPORTED CONTAMINATED DEVICES AT THE FACILITY (SEE MEDWATCH REPORTS 9611109-2016-00965, 9611109-2018-00205 AND 9611109-2018-00204). HOWEVER, MULTIPLE OTHER UNITS HAVE NOT TESTED POSITIVE FOR CONTAMINATION AND IT IS UNKNOWN WHICH UNIT WAS USED DURING THE PROCEDURE ON THIS PATIENT. THE CUSTOMER HAS NOT REPORTED ANY CONFIRMED LINK BETWEEN THE PATIENT INFECTION AND THE USE OF THE HEATER-COOLER DEVICE. 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 WAS DIAGNOSED WITH A MYCOBACTERIUM CHIMAERA INFECTION FOLLOWING HEART VALVE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209461 HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND 16-02-80

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| O