BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEATER-COOLER SYSTEM 3T

    MDR report key: 10755735 · Received October 29, 2020

    Report

    Report Number
    9611109-2020-00601
    Event Type
    Malfunction
    Date Received
    October 29, 2020
    Date of Event
    September 29, 2020
    Report Date
    October 26, 2020
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWC
    PMA / PMN Number
    K191402
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT INVOLVEMENT. LIVANOVA (B)(4) MANUFACTURES THE HEATER-COOLER SYSTEM 3T . THE INCIDENT OCCURRED IN (B)(6). THE TECHNICIAN IN CHARGE CONFIRMED THE REPORTED ISSUE AND TRACED IT BACK TO THE PATIENT PUMP. THE PART WAS REPLACED AND THE ISSUE SOLVED. SUBSEQUENT FUNCTIONAL VERIFICATION TESTING WAS COMPLETED WITHOUT FURTHER ISSUES AND THE UNIT WAS RETURNED TO SERVICE. THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT IS BEARING CORROSION FORMATION DUE TO ENVIRONMENTAL CONDITION IN WHICH THE PUMP WORKED.

    Description of Event or Problem · 1

    LIVANOVA (B)(4) RECEIVED A REPORT THAT A HEATER-COOLER SYSTEM 3T DISPLAYED AN ERROR CODE ASSOCIATED TO PATIENT PUMPS DURING SETUP. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1223827 HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND 16-02-85

    Patients

    Seq Age Sex Outcome Treatment
    1