BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEATER-COOLER SYSTEM 3T

    MDR report key: 8315570 · Received February 7, 2019

    Report

    Report Number
    9611109-2019-00060
    Event Type
    Death
    Date Received
    February 7, 2019
    Date of Event
    May 11, 2015
    Report Date
    February 7, 2019
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWC
    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

    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). 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 THE UNITED STATES. THE CUSTOMER FILED A USER REPORT (MW5082707) WITH NO CONTACTS, DEVICE SERIAL NUMBER OR HOSPITAL INFORMATION THUS, NO FURTHER FOLLOW-UP IS POSSIBLE AT THIS TIME. HOWEVER, IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. SINCE IT IS UNKNOWN WHICH UNIT WAS USED ON THE PATIENT, NO SERVICE HISTORY CHECK, NOR A DEVICE HISTORY CHECK COULD BE PERFORMED. HOWEVER, CORRECTIVE ACTIONS ARE IN PROGRESS FOR THIS ISSUE. IT IS UNKNOWN WHICH UNIT WAS USED.

    Description of Event or Problem · 1

    LIVANOVA (B)(4) RECEIVED A MEDWATCH REPORT (MW5082707) IN WHICH IT IS STATED THAT A PATIENT, WHO UNDERWENT SURGERY (B)(6) 2015 DURING WHICH A HEATER COOLER 3T WAS USED, HAS DIED ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106926 HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND 16-02-85

    Patients

    Seq Age Sex Outcome Treatment
    1 Death