BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEATER-COOLER SYSTEM 3T

    MDR report key: 8472403 · Received April 2, 2019

    Report

    Report Number
    9611109-2019-00214
    Event Type
    Injury
    Date Received
    April 2, 2019
    Date of Event
    October 24, 2018
    Report Date
    April 2, 2019
    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
    003

    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. 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 DEUTSCHLAND IMPLEMENTED A FIELD SAFETY NOTICE FOR DISINFECTION AND CLEANING OF HEATER-COOLER DEVICES. THE Z NUMBER IS Z-2076/2081-2015. LIVANOVA DEUTSCHLAND MANUFACTURES THE HEATER-COOLER SYSTEM 3T. THE INCIDENT OCCURRED IN (B)(6). CORRECTIVE ACTIONS ARE IN PROGRESS FOR THAT 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 DEUTSCHLAND IDENTIFIED AN ARTICLE WHICH STATED THAT A PATIENT, WHO UNDERWENT A SURGERY ON (B)(6) 2018, WAS FOUND TO BE INFECTED WITH SOME SORT OF BACTERIUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267268 HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND 16-02-80

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| O