BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEATER/COOLER 3T 110V/60 HZ

    MDR report key: 15948376 · Received December 9, 2022

    Report

    Report Number
    9611109-2022-00637
    Event Type
    Malfunction
    Date Received
    December 9, 2022
    Date of Event
    November 9, 2022
    Report Date
    November 9, 2022
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWC
    PMA / PMN Number
    K191402
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H10: COMPLAINTS DATABASE ANALYSIS REVEALED THAT NO SIMILAR EVENT ON THIS DEVICE OCCURRED SINCE ITS INSTALLATION IN 2014. THE MOST LIKELY ROOT CAUSE OF THE REPORTED ISSUE IS ASSOCIATED TO MOTOR BEARING DAMAGED BY THE CORROSION, WHICH CONSEQUENTLY DOES NOT ALLOW THE MOTOR SHAFT TO ROTATE. POSSIBLE CAUSES ARE WATER INFILTRATION OR WATER FORMATION DUE TO CONDENSATION OR HIGH TEMPERATURES AND HIGH LEVEL OF HUMIDITY IN THE STATIONARY PHASE. CAUSES RELATED TO ENVIRONMENTAL CONDITIONS.

    Additional Manufacturer Narrative · 0

    LIVANOVA DEUTSCHLAND MANUFACTURES THE HEATER-COOLER SYSTEM 3T . THE INCIDENT OCCURRED IN UNITED STATES. A LIVANOVA FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO THE FACILITY TO INVESTIGATE THE DEVICE AND THE ERROR EE7 WAS CONFIRMED ON THE PATIENT SIDE. THE CIRCULATOR MOTOR (ITEM 96-410-719) AND EROSION KIT (ITEM 005-21-0061) WERE REPLACED. THE DEVICE WAS TESTED AND 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

    SEE INITIAL REPORT.

    Description of Event or Problem · 0

    LIVANOVA DEUTSCHLAND RECEIVED A REPORT THAT A 3T HEATER-COOLER DEVICE DISPLAYED A TEMPERATUR PROBLEM ERROR (E07) DURING MAINTENANCE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2701882 HEATER/COOLER 3T 110V/60 HZ CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND 16-02-85

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown