BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA CIRCULATORY SUPPORT SYSTEM CONSOLE

    MDR report key: 1021889 · Received March 28, 2008

    Report

    Report Number
    3003761017-2008-00009
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Date of Event
    March 4, 2008
    Report Date
    March 27, 2008
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE VACUUM WAS NOT INITIATED AS EXPECTED WHEN THE CONTROL KNOB WAS TURNED ON CSS CONSOLE 28. THE PT WAS SWITCHED TO A BACKUP CSS CONSOLE. THERE WAS NO PT IMPACT. A SYNCARDIA CLINICAL SUPPORT REP REMOVED THE ALARM PANEL AND OBSERVED THAT THE POTENTIOMETER HOUSING WAS PHYSICALLY BROKEN. THIS ALLEGED FAILURE MODE POSES A LOW RISK TO THE PT BECAUSE THE EFFECT OF A POTENTIOMETER MALFUNCTION DOES NOT NEGATE THE ABILITY OF THE CSS CONSOLE TO PERFORM ITS LIFE-SUSTAINING FUNCTIONS, AS THE CSS CONSOLE DOES NOT REQUIRE VACUUM TO ACHIEVE APPROPRIATE CARDIAC OUTPUT. SYNCARDIA HAS REQUESTED THAT THE CSS CONSOLE BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCARDIA CIRCULATORY SUPPORT SYSTEM CONSOLE CIRCULATORY ASSIST DEVICE DSQ SYNCARDIA SYSTEMS, INC. CSS CONSOLE 28

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR