BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEATER-COOLER SYSTEM 3T

    MDR report key: 8669806 · Received June 5, 2019

    Report

    Report Number
    9611109-2019-00405
    Event Type
    Death
    Date Received
    June 5, 2019
    Report Date
    June 5, 2019
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWC
    PMA / PMN Number
    K052601
    Removal / Correction Number
    Z-2076/2081-2015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT PROVIDED. SERIAL NUMBER IS UNKNOWN. THIS INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT IF MADE AVAILABLE. 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). THROUGH FOLLOW UP COMMUNICATION, LIVANOVA DEUTSCHLAND LEARNED THAT ALL HEATER-COOLER SYSTEMS 3T OF THE (B)(6) MEDICAL CENTER WERE REMOVED FROM SERVICE AND WERE REPLACED WITH COMPETITOR UNITS. CORRECTIVE ACTIONS ARE IN PROGRESS FOR THIS ISSUE. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    LIVANOVA (B)(4) LEARNED THROUGH THE PAPER 'MYCOBACTERIA CHIMAERA INFECTIONS ASSOCIATED WITH HEATER-COOLER UNIT USE DURING CARDIOPULMONARY BYPASS SURGERY ¿ (B)(6) COUNTY, 2012¿2016' IN THE MORBIDITY AND MORTALITY WEEKLY REPORT (MMWR) / JANUARY 4, 2019 / VOL. 67 / NOS. 51 & 52 US DEPARTMENT OF HEALTH AND HUMAN SERVICES/CENTERS FOR DISEASE CONTROL AND PREVENTION THAT BY MAY 2017, 20 CONFIRMED CASES OF MYCOBACTERIUM CHIMAERA INFECTION HAD BEEN IDENTIFIED IN PATIENTS WITH A HISTORY OF CARDIOPULMONARY BYPASS DURING 2013¿2016. AS OF MAY 2019 LIVANOVA (B)(4) HAS CAPTURED 9 COMPLAINTS ON PATIENT INFECTION, EACH IN THE HOSPITAL CALLED (B)(6). THIS REPORT CAPTURES THE 11 CASES OF INFECTIONS NOT YET CAPTURED IN COMPLAINTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463139 HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND 16-02-85

    Patients

    Seq Age Sex Outcome Treatment
    1 Death