BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEATER-COOLER SYSTEM 3T

    MDR report key: 11938714 · Received June 4, 2021

    Report

    Report Number
    9611109-2021-00305
    Event Type
    Malfunction
    Date Received
    June 4, 2021
    Date of Event
    January 14, 2021
    Report Date
    August 24, 2021
    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

    THE UNIT WAS REMOVED FROM SERVICE. ON (B)(6) 2019 IT WAS PERFORMED THE EROSION KIT UPGRADE (005-21-0061) ACCORDING TO THE FCO_2017-002 (RETROFIT/VACUUM UPGRADE OF LIVANOVA HC-3T - EROSION KIT) OF THE DEVICES THAT INCLUDES THE NEW DESIGN OF THE PUMP HEAD OF THE STIRRER MOTOR TO PREVENT A WATER FLOW DIRECTED TO A NARROW AREA OF THE EVAPORATOR COIL. THE ISSUE WAS CLAIMED ABOUT ONE YEAR AFTER THE UPGRADE, BUT MOST PROBABLY THE CONDITION OF THE EVAPORATOR WAS ALREADY COMPROMISED BEFORE THE UPGRADE TO SUCH AN EXTENT THAT THE COPPER WAS RATHER DEGRADED. NO OTHER SPECIFIC ACTION WAS CURRENTLY DEEMED NECESSARY, LIVANOVA MAINTAINS AND DOCUMENT PERIODIC CUSTOMER EVENTS MONITORING PROCESS IN ORDER TO EVALUATE ACTIONS FOR PRODUCTS IMPROVEMENT.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT INVOLVEMENT. THE HEATER-COOLER 16-02-80 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). A LIVANOVA FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO THE FACILITY TO INVESTIGATE THE DEVICE AND COULD CONFIRM THE REPORTED ISSUE. IT WAS FOUND THAT THE POWER TRIPPED AS SOON AS THE COMPRESSOR WAS ACTIVATED. THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT IS A COMPRESSOR DAMAGE DUE TO DEGRADATION LEADING TO A BREACH OF THE COOLING COIL. THIS HOLE OF THE COOLING COIL CAUSES REFRIGERANT LEAK AND WATER ENTERING THE REFRIGERATION CYCLE CONSEQUENTLY DAMAGING THE COMPRESSOR. 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 TRIPPED THE ELECTRICAL POWER CIRCUITS DURING ROUTINE CLEANING AND WATER CHANGE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836946 HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND 16-02-80

    Patients

    Seq Age Sex Outcome Treatment
    1