BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAIRFIELD MED CTR OH 1

    MDR report key: 23618595 · Received November 21, 2025

    Report

    Report Number
    1718850-2025-90011
    Event Type
    Malfunction
    Date Received
    November 21, 2025
    Date of Event
    October 23, 2025
    Report Date
    May 20, 2026
    Manufacturer
    LIVANOVA USA INC.
    Product Code
    DWE
    PMA / PMN Number
    K981613
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A1-A5 PATIENT INFORMATION WAS NOT PROVIDED. D.4. LOT NUMBER IS UNKNOWN. THIS INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT IF MADE AVAILABLE. H.4. AS THE LOT NUMBER IS UNKNOWN, THE DEVICE MANUFACTURING DATE COULD NOT BE DETERMINED. THIS INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT IF MADE AVAILABLE. H.11 LIVANOVA USA INC. MANUFACTURES THE SMART PERFUSION PACK. THE EVENT 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 · 0

    LIVANOVA USA HAS RECEIVED A REPORT INDICATING DISCONNECTION OF THE 3/8" MAIN VENOUS LINE FROM THE RESERVOIR. THERE IS NO REPORT OF ANY PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584921 FAIRFIELD MED CTR OH 1 TUBING, PUMP, CARDIOPULMONARY BYPASS DWE LIVANOVA USA INC. FAIRFIELD MED CTR OH 1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown