BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEMHEART PUMP

    MDR report key: 1048905 · Received May 21, 2008

    Report

    Report Number
    2531527-2008-00006
    Event Type
    Malfunction
    Date Received
    May 21, 2008
    Date of Event
    April 25, 2008
    Report Date
    May 16, 2008
    Manufacturer
    CARDIAC ASSIST, INC.
    Product Code
    KFM
    PMA / PMN Number
    K991783
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: AN EVALUATION WAS CONDUCTED UPON RECEIPT WHICH CONFIRMED THAT THE PUMP WAS NON-FUNCTIONAL. ANALYSIS OF THE PUMP FOUND EVIDENCE OF BLOOD IN THE LOWER HOUSING OF THE PUMP, AS WELL AS DAMAGE TO THE INTERNAL BEARING COMPONENTS WHICH RESULTED IN THE PUMP FAILURE. SUCH DAMAGE HAS BEEN PREVIOUSLY DEMONSTRATED TO RESULT FROM LOSS OF INFUSION FLOW THROUGH THE BEARING PORTIONS OF THE PUMP. THE CAUSE OF THE LOSS OF INFUSION FLOW COULD NOT BE ESTABLISHED.

    Description of Event or Problem · 1

    THE CLINICAL STAFF OF THE HOSPITAL CONTACTED CARDIACASSIST TO REPORT THAT A PUMP HAD STOPPED AFTER APPROXIMATELY 8 DAYS OF USE. PRIOR TO THE FAILURE, IT WAS NOTED THAT THE STAFF HAD DIFFICULTY CHANGING THE INFUSION ASSEMBLY AND THAT THE INFUSATE FLOW TO THE PUMP HAD BEEN STOPPED FOR AN EXTENDED PERIOD OF TIME. IT WAS ALSO OBSERVED THAT THE PUMP CURRENT HAD INCREASED AFTER THE DIFFICULTIES IN CHANGING THE INFUSION ASSEMBLY AND WAS CONTINUING TO RISE. THE STAFF WAS PREPARING TO CHANGE THE PUMP WHEN THE CONTROLLER ALARMED AND THE PUMP STOPPED. THE PUMP WAS REPLACED AND RESTARTED, AND THE PATIENT WAS REPORTEDLY NOT ADVERSELY IMPACTED BY THE BRIEF INTERRUPTION IN SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TANDEMHEART PUMP NON-ROLLER TYPE BYPASS PUMP KFM CARDIAC ASSIST, INC. TANDEMHEART

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention