BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFESPARC SYSTEM

    MDR report key: 12006261 · Received June 16, 2021

    Report

    Report Number
    2531527-2021-00024
    Event Type
    Injury
    Date Received
    June 16, 2021
    Date of Event
    May 15, 2021
    Report Date
    August 24, 2021
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    KFM
    PMA / PMN Number
    K183623
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    STAFF NOTICED SIGNS OF CLOTS INSIDE THE PUMP AND FOR THIS REASON, A NEW CIRCUIT WAS PRIMED AND CHANGED OUT. PATIENT NEEDED CPR. THE ISSUE OCCURRED AFTER 26 DAYS OF SUPPORT AND ANTI-COAGULATION THERAPY WAS CONTINUALLY STOPPED AND REACTIVATED DUE TO BLEEDING. THE DEVICE WAS NOT MADE AVAILABLE FOR RETURN AND INVESTIGATION, CLEAR PICTURE OF PUMP WAS PROVIDED SHOWING VISIBLE SIGNS OF BIOLOGIC DEPOSIT IN THE UPPER HOUSING. DHR REVIEW HAS NOT POINTED OUT ANY DEVIATIONS OR NON-CONFORMITIES POSSIBLY RELEVANT TO OCCURRED ISSUE. BASED ON THE INVESTIGATION RESULTS, CONSIDERING THE PATIENT CONDITION AND THAT UNIT WAS WORKING CORRECTLY FOR 26 DAYS, IT CANNOT BE RULED OUT THAT THE MOST LIKELY ROOT CAUSE OF CLOT/THROMBUS FORMATION PROBABLY CAUSED BY CONTINUOUS STOPPING OF ANTICOAGULATION THERAPY. NO OTHER SPECIFIC ACTION WAS CURRENTLY DEEMED NECESSARY, LIVANOVA MAINTAINS AND DOCUMENT PERIODIC CUSTOMER EVENTS MONITORING PROCESS IN ORDER TO EVALUATE ACTIONS FOR PRODUCTS IMPROVEMENT.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT PROVIDED. CARDIACASSIST INC. MANUFACTURES THE LIFESPARC SYSTEM. THE INCIDENT OCCURRED IN (B)(6) . LIVANOVA INITIATED AN INVESTIGATION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    LIVANOVA RECEIVED REPORT THAT THE PATIENT WAS ON SUPPORT SINCE (B)(6) 2021. ON (B)(6) 2021, A PUMP SPEED ERROR OCCURRED ON A LIFESPARC PUMP. INSPECTION OF THE PUMP WHILE SPEED ERROR WAS DISPLAYED REVEALED PRESENCE OF CLOT. WITHIN 30-45 MINUTES THE PUMP STOPPED. THE STAFF WAS PREPARED, AND A NEW CIRCUIT WAS CONNECTED AND PATIENT WAS BACK ON SUPPORT. THE PATIENT DID NEED CPR AND UNDERWENT TO CT SCAN FOR A HEAD SCAN. HE HAD BEEN ON AND OFF ANTICOAGULANTS FOR A FEW DAYS. THE PERFUSION CLEANED OUT THE PUMP AND NOTICED THAT THERE WERE A LOT OF CLOTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    908917 LIFESPARC SYSTEM PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM LIVANOVA DEUTSCHLAND 5800-0000

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention