BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEATER-COOLER SYSTEM 3T

    MDR report key: 7832372 · Received August 30, 2018

    Report

    Report Number
    9611109-2018-01192
    Event Type
    Malfunction
    Date Received
    August 30, 2018
    Date of Event
    November 21, 2017
    Report Date
    August 30, 2018
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT INVOLVEMENT. THE HEATER-COOLER 16-02-80 IS NOT DISTRIBUTED IN THE USA. THE UDI NUMBER IS NOT APPLICABLE. 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). LIVANOVA (B)(4) MANUFACTURES THE HEATER-COOLER SYSTEM 3T. THE INCIDENT OCCURRED IN (B)(6). THE SERVICE TECHNICIAN REPLACED THE MAIN BOARD TO SOLVE THE ISSUE AND SENT IT TO MANUFACTURER FOR FURTHER INVESTIGATION. THE INVESTIGATION RESULT REVEALED DEFECTIVE ELECTRONIC PARTS. HOWEVER THE ROOT CAUSE CANNOT BE DETERMINED WITHOUT THE WHOLE UNIT. A REVIEW OF THE DHR COULD NOT IDENTIFY ANY DEVIATIONS OR NONCONFORMITIES RELEVANT TO THE ISSUE. SINCE NO SPECIFIC TREND COULD BE IDENTIFIED FOR THIS TYPE OF ISSUE, LIVANOVA (B)(4) HAS DETERMINED THAT A CAPA IS NOT NEEDED. LIVANOVA (B)(4) WILL CONTINUE TO MONITOR THE MARKET FOR TRENDS RELATED TO THIS TYPE OF ISSUE.

    Description of Event or Problem · 1

    LIVANOVA (B)(4) RECEIVED A REPORT THAT AN ERROR OCCURED ON A HEATER/COOLER 3T. THIS ISSUE WAS IDENTIFIED BY A LIVANOVA FIELD SERVICE REPRESENTATIVE DURING ROUTINE MAINTENANCE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675809 HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND 16-02-80

    Patients

    Seq Age Sex Outcome Treatment
    1