BEUDAMED
    FDA Recall Terminated

    LivaNova Heater-Cooler System 3T - Product Usage: The Heater-Cooler 3T System is used to circulate water through heat exchangers to warm or cool a patient during cardiopulmonary bypass procedures lasting 6 hours or less.

    Recall: Z-1498-2020 · Initiated February 24, 2020

    Recall

    Recall Number
    Z-1498-2020
    Event Number
    85098
    Firm
    LivaNova USA Inc.
    FEI Number
    1718850
    Product Code
    DWC
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    February 24, 2020
    Terminated
    August 4, 2022
    Address
    14401 W 65th Way, Arvada, CO, 80004-3503

    Description

    LivaNova Heater-Cooler System 3T - Product Usage: The Heater-Cooler 3T System is used to circulate water through heat exchangers to warm or cool a patient during cardiopulmonary bypass procedures lasting 6 hours or less.

    Reason

    The firm is providing validated cleaning and disinfection instructions in their revised operating instructions to reduce the risk of NTM contamination.

    Action

    On 02/24/2020, the firm sent an "URGENT MEDICAL DEVICE CORRECTION" Letter to customers informing them that the firm is executing a voluntary correction for their Heater-Cooler Systems and providing customers with a recently cleared operating instructions that includes a validated instructions for cleaning and disinfecting the external surfaces, connectors, fittings, and water circuits. The firm is instructing customers to discard or destroy older versions of the operating instruction and advising that all Heater-Cooler Systems in use at their facility should be upgraded with the 3T Aerosol Collection Set (vacuum canister and internal seal) to further reduce the risk of potential aerosol emission form the 3T system. These corrections apply to all 3T Systems currently in distribution, which includes upgrading any loaners that were previously distributed or that are pending distribution. Actions to be Taken by the Customer/User Use the Validated Operating Instructions Provided with this Customer Letter " The FDA cleared Operating Instructions are found in Attachment 1 as well as at Product Resources on www.livanova.com. - Please read and follow the instructions carefully. - Section 2.1.5 Integrating the HC3T into your facility provides guidance on the use of the 3T System in your facility, highlighting critical tasks that users had the most difficulty with during human factors testing. - Section 6 Maintaining the heater-cooler provides guidance on the maintenance of the 3T System including the validated cleaning and disinfection instructions. - Section 7.1.4 General performance data describes performance testing results that emphasize the importance of following the cleaning and disinfection instructions and consistently using the 3T Aerosol Collection Set during surgeries. Specifically, these results describe how (1) the disinfection and water maintenance process maintains water quality and (2) the 3T Aerosol Collection Set design change reduces the

    Distribution

    U.S. Nationwide distribution including Puerto Rico. This matter was triggered by the clearance of K191402, thus only the United States, including Puerto Rico, is affected. O.U.S. - none

    Quantity

    Total Worldwide=9309 systems (2713 system in U.S.)