BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEATER-COOLER SYSTEM 3T

    MDR report key: 7751172 · Received August 6, 2018

    Report

    Report Number
    9611109-2018-01137
    Event Type
    Death
    Date Received
    August 6, 2018
    Date of Event
    January 7, 2016
    Report Date
    December 11, 2018
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWC
    Removal / Correction Number
    Z-2076/2081-2015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERIAL NUMBER IS UNKNOWN. THIS INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT IF MADE AVAILABLE. 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). AS THE SERIAL NUMBER IS UNKNOWN, THE DEVICE MANUFACTURE DATE COULD NOT BE DETERMINED. THIS INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT IF MADE AVAILABLE. 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.

    Additional Manufacturer Narrative · 1

    LIVANOVA (B)(4) WAS INFORMED THAT THE PATIENT PASSED AWAY ON (B)(6) 2018. LIVANOVA (B)(4) REQUESTED FURTHER INFORMATION SEVERAL TIMES WHICH WERE NOT MADE AVAILABLE. THEREFORE NO FURTHER INVESTIGATION CAN BE PERFORMED. AS NO FURTHER INFORMATION WAS PROVIDED THE REPORTED ISSUE COULD NOT BE CONFIRMED OR REPRODUCED. CORRECTIVE ACTIONS ARE IN PROGRESS FOR THIS ISSUE.

    Description of Event or Problem · 1

    LIVANOVA (B)(4) RECEIVED A REPORT THAT A PATIENT WAS FOUND TO BE INFECTED WITH MYCOBACTERIUM CHIMAERA. THE PATIENT WAS INITIALLY OPERATED IN (B)(6) 2016 HOWEVER DUE TO AN ENDOCARDITIS CAUSE BY THE MYCOBACTERIUM CHIMAERA INFECTION AN ADDITIONAL SURGERY WAS NECESSARY. THE CUSTOMER REPORTED THAT A HEATER-COOLER SYSTEM 3T WAS USED DURING THE FIRST SURGERY.

    Description of Event or Problem · 1

    SEE INITIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592950 HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND 16-02-80

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death| L| O