BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEATER-COOLER SYSTEM 3T

    MDR report key: 13223433 · Received January 11, 2022

    Report

    Report Number
    9611109-2022-00014
    Event Type
    Malfunction
    Date Received
    January 11, 2022
    Date of Event
    November 1, 2021
    Report Date
    January 11, 2022
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWC
    UDI-DI
    04033817901099
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS NO PATIENT INVOLVEMENT. 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: K191402). LIVANOVA (B)(4) MANUFACTURES THE HEATER-COOLER SYSTEM 3T. THE INCIDENT OCCURRED IN (B)(6). A LIVANOVA FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO THE FACILITY TO INVESTIGATE THE DEVICE AND COULD CONFIRM THE REPORTED ISSUE. THE FAILURE WAS TRACED BACK TO INSUFFICIENT REFRIGERANT INSIDE THE COMPRESSOR. THE REFRIGERANT WAS ADDED AND THE DEVICE RESUMED TO NORMAL FUNCTION. SUBSEQUENT FUNCTIONAL VERIFICATION TESTING WAS COMPLETED WITHOUT FURTHER ISSUES AND THE UNIT WAS RETURNED TO SERVICE. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    THERE WAS NO PATIENT INVOLVEMENT. 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: K191402). LIVANOVA (B)(4) MANUFACTURES THE HEATER-COOLER SYSTEM 3T. THE INCIDENT OCCURRED IN (B)(6). A LIVANOVA FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO THE FACILITY TO INVESTIGATE THE DEVICE AND COULD CONFIRM THE REPORTED ISSUE. THE FAILURE WAS TRACED BACK TO INSUFFICIENT REFRIGERANT INSIDE THE COMPRESSOR. THE REFRIGERANT WAS ADDED AND THE DEVICE RESUMED TO NORMAL FUNCTION. SUBSEQUENT FUNCTIONAL VERIFICATION TESTING WAS COMPLETED WITHOUT FURTHER ISSUES AND THE UNIT WAS RETURNED TO SERVICE. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    LIVANOVA (B)(4) RECEIVED A REPORT THAT A HEATER-COOLER SYSTEM 3T AFTER RUNNING FOR ABOUT 20 MINUTES SHOWED COOLING SYSTEM NOT WORKING NORMALLY DURING A PROCEDURE. THE COOLING PROCESS WAS SLOW SO THE OPERATION COULD NOT BE CARRIED OUT SMOOTHLY, AND THE DEVICE WAS REPLACED WITH ANOTHER. THERE WAS NO REPORT OF PATIENT INJURY.

    Description of Event or Problem · 0

    LIVANOVA (B)(4) RECEIVED A REPORT THAT A HEATER-COOLER SYSTEM 3T AFTER RUNNING FOR ABOUT 20 MINUTES SHOWED COOLING SYSTEM NOT WORKING NORMALLY DURING A PROCEDURE. THE COOLING PROCESS WAS SLOW SO THE OPERATION COULD NOT BE CARRIED OUT SMOOTHLY, AND THE DEVICE WAS REPLACED WITH ANOTHER. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754833 HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND 16-02-80 04033817901099

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown