BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEATER-COOLER SYSTEM 3T

    MDR report key: 10895541 · Received November 24, 2020

    Report

    Report Number
    9611109-2020-00648
    Event Type
    Malfunction
    Date Received
    November 24, 2020
    Date of Event
    October 26, 2020
    Report Date
    November 23, 2020
    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 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). THROUGH FOLLOW-UP COMMUNICATION LIVANOVA LEARNED THAT THE CUSTOMER MAINTAINS ITS OWN EQUIPMENT THUS NO LIVANOVA TECHNICIAN WAS DISPATCHED TO THE FACILITY. THE CUSTOMER ORDERED A NEW POWER CABLE TO SOLVE THE PROBLEM AND A LIVANOVA SERVICE TECHNICIAN PROVIDED SUPPORT VIA PHONE. BASED ON THE AVAILABLE INFORMATION, THE REPORTED EVENT WAS MOST LIKELY CAUSED BY A DAMAGED POWER CABLE.

    Description of Event or Problem · 1

    LIVANOVA (B)(4) RECEIVED A REPORT OF A HEATER-COOLER SYSTEM 3T SHUT-DOWN DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1361682 HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND 16-02-85

    Patients

    Seq Age Sex Outcome Treatment
    1