BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEATER-COOLER SYSTEM 3T

    MDR report key: 10424262 · Received August 19, 2020

    Report

    Report Number
    9611109-2020-00468
    Event Type
    Malfunction
    Date Received
    August 19, 2020
    Date of Event
    July 20, 2020
    Report Date
    July 20, 2020
    Manufacturer
    LIVANOVA DEUTSCHLAND GMBH
    Product Code
    DWC
    PMA / PMN Number
    K191402
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO KNOWN PATIENT INVOLVEMENT. PMA/510(K). 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 UNITED STATES. LIVANOVA INITIATED AN INVESTIGATION. 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 RECEIVED A REPORT OF HEATERCOOLER WITH WATER LEAK FROM THE BOTTOM OF THE TANK. NO INFORMATION OF ANY PATIENT/USER INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    889478 HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND GMBH 16-02-85

    Patients

    Seq Age Sex Outcome Treatment
    1