BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEATER-COOLER SYSTEM 3T

    MDR report key: 18423800 · Received January 2, 2024

    Report

    Report Number
    9611109-2024-00002
    Event Type
    Malfunction
    Date Received
    January 2, 2024
    Date of Event
    December 7, 2023
    Report Date
    April 15, 2024
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWC
    UDI-DI
    04033817900528
    PMA / PMN Number
    K191402
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A.1.-A.5. THERE WAS NO PATIENT INVOLVEMENT. H10: LIVANOVA DEUTSCHLAND MANUFACTURES THE HEATER-COOLER SYSTEM 3T. THE INCIDENT OCCURRED IN ST PETERSBURG, FLORIDA. A LIVANOVA FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO THE FACILITY TO INVESTIGATE THE DEVICE AND COULD CONFIRM THE REPORTED ISSUE: STIRRER MOTOR WAS COMPLETELY BLOCKED. THE TECHNICIAN WAS ABLE TO GET IT TO SPIN, HOWEVER IT WAS VERY NOISY, THEREFORE IT WAS REPLACED. 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

    H10: BASED ON THE COLLECTED INFORMATION AND TAKING INTO ACCOUNT THE REVIEW OF SIMILAR EVENTS, THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT WAS IDENTIFIED IN A MECHANICAL JAMMING OF THE STIRRING MECHANISM DUE TO MOTOR BEARING DAMAGED BY THE CORROSION, WHICH CONSEQUENTLY DOES NOT ALLOW THE MOTOR SHAFT TO ROTATE. POSSIBLE CAUSES THAT MAY HAVE CONTRIBUTED TO THE FAILURE OF THE MOTOR OVER TIME ARE WATER INFILTRATION OR WATER FORMATION DUE TO CONDENSATION OR HIGH TEMPERATURES AND HIGH LEVEL OF HUMIDITY IN THE STATIONARY PHASE.

    Description of Event or Problem · 0

    LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A HEATER-COOLER SYSTEM 3T DISPLAYED AN ERROR MESSAGE ASSOCIATED TO STIRRING MECHANISM BLOCKED (TOO SLOW) AT START UP AND THE ERROR WOULD NOT CLEAR. THERE WAS NO PATIENT INJURY.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1451011 HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND 16-02-85 04033817900528

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown