BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEATER-COOLER SYSTEM 3T

    MDR report key: 10612595 · Received October 1, 2020

    Report

    Report Number
    9611109-2020-00554
    Event Type
    Malfunction
    Date Received
    October 1, 2020
    Date of Event
    September 4, 2020
    Report Date
    September 30, 2020
    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

    H.10: THE AFFECTED DEVICE WAS RETURNED BACK TO THE MANUFACTURER SITE FOR INVESTIGATION. THE ROOT CAUSE CAUSE WAS A DAMAGED COMPRESSOR.

    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). THE SERVICE TECHNICIAN IN CHARGE VERIFIED THAT THE DEVICE TRIPPED THE MAINS POWER WHEN THE COOLING COMPRESSOR HAD STARTED POINTING TO A DEFECTIVE COMPRESSOR AS ROOT CAUSE OF THE REPORTED ISSUE. IN ADDITION A BUBBLING SOUND COULD BE HEARD FROM THE PATIENT TANK SUGGESTING A LEAK OF COOLANT. 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 OF A HEATER-COOLER SYSTEM 3T SHUTDOWN DURING A SERVICE ACTIVITY. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1077339 HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND 16-02-80

    Patients

    Seq Age Sex Outcome Treatment
    1