BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEATER-COOLER SYSTEM 3T

    MDR report key: 10641555 · Received October 7, 2020

    Report

    Report Number
    9611109-2020-00561
    Event Type
    Malfunction
    Date Received
    October 7, 2020
    Date of Event
    September 9, 2020
    Report Date
    October 5, 2020
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THROUGH FOLLOW-UP COMMUNICATION LIVANOVA LEARNED THAT THE ERROR CODE WAS DISPLAYED ON THE PATIENT SIDE AND THAT WAD DUE TO A DEFECTIVE STIRRER MOTOR. THE MOTOR WAS REPLACED AS WELL AS DISTRIBUTION BOARD AND CPU BOARD. SUBSEQUENT FUNCTIONAL VERIFICATION TESTING WAS COMPLETED WITHOUT FURTHER ISSUES AND THE UNIT WAS RETURNED TO SERVICE.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Additional Manufacturer Narrative · 1

    THERE WAS NO KNOWN PATIENT INVOLVEMENT. THE HEATER-COOLER 16-02-95 IS NOT DISTRIBUTED IN THE USA AND IT IS SIMILAR TO HEATER-COOLER 16-02-85, WHICH IS DISTRIBUTED IN THE USA (510(K) NUMBER: K191402). LIVANOVA (B)(4) MANUFACTURES THE HEATER-COOLER SYSTEM 3T . THE INCIDENT OCCURRED IN (B)(6). LIVANOVA INITIATED AN INVESTIGATION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    LIVANOVA (B)(4) RECEIVED A REPORT THAT A HEATER-COOLER SYSTEM 3T DISPLAYED AN ERROR CODE DURING SETUP. THE SIDE AFFECTED (PATIENT OR CARDIOPLEGIA) IS STILL UNKNOWN. A MALFUNCTION OF THE STIRRER MOTOR CANNOT BE EXCLUDED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1105729 HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND 16-02-95

    Patients

    Seq Age Sex Outcome Treatment
    1