BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCARDIA CIRCULATORY SUPPORT SYSTEM CONSOLE

    MDR report key: 4762848 · Received May 7, 2015

    Report

    Report Number
    3003761017-2015-00131
    Event Type
    Death
    Date Received
    May 7, 2015
    Date of Event
    April 12, 2015
    Report Date
    April 12, 2015
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER ALSO REPORTED THAT THE CSS CONSOLE PASSED A CONSOLE VALIDATION TEST PROTOCOL FOLLOWING THE REPORTED EVENT. THE CUSTOMER ALSO REPORTED THAT SINCE THE CSS CONSOLE WAS PERFORMING AS INTENDED, IT WILL NOT BE RETURNED TO SYNCARDIA FOR EVALUATION. THE ROOT CAUSE OF THE "LEAKY PILOT VALVE" ALARMS HAVE PREVIOUSLY BEEN INVESTIGATED AT SYNCARDIA. THIS IS A CALIBRATION ISSUE THAT SOMETIMES CAN BE RESOLVED BY ADJUSTING THE SHIMS WITHIN THE CLIPPARD VALVES. POSITIONING OF THE SHIMS WITH THE CLIPPARD VALVE BODY AFFECTS THE TIMING AND SHAPE OF THE FLOW WAVEFORMS, AND CAN POTENTIALLY CAUSE LEAKAGE AND/OR DRIFT. TYPICALLY, ADJUSTMENT IS NOT NECESSARY, BUT IN SOME INSTANCES, IT ASSISTS IN BRINGING THE WAVE FORM INTO CALIBRATION. IN THIS CASE, ADJUSTMENT OF THE SHIMS WAS NOT REQUIRED. THIS CALIBRATION ISSUE DID NOT PRESENT A RISK TO THE OPERATIONAL STABILITY OF THE CSS CONTROLLER BUT RATHER PRESENTED A BORDERLINE WAVEFORM WHICH, AT TIMES, WAS JUST OUTSIDE OF THE ACCEPTABLE WAVEFORM LIMITS, CAUSING CALIBRATION FAILURE. THE REPORTED ISSUES POSED A LOW RISK TO THE PT BECAUSE ALTHOUGH THE CSS CONSOLE EXHIBITED A "LEAKY PILOT VALVE ALARM," THE CSS CONSOLE CONTINUED TO PERFORM ITS LIFE-SUSTAINING FUNCTIONS. THIS ISSUE WILL CONTINUE TO BE MONITORED AND TRENDED AS PART OF THE CUSTOMER EXPERIENCE PROCESS. SYNCARDIA HAS COMPLETED ITS EVALUATION OF THIS COMPLAINT AND IS CLOSING THIS FILE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE TAH-T PT WAS TRANSFERRED FROM A FREEDOM DRIVER TO THIS CSS CONSOLE FOLLOWING EMERGENCY ADMITTANCE TO THE OPERATING ROOM (OR) FOR SURGERY, FOR TAMPONADE. THE CUSTOMER ALSO REPORTED THAT THE CSS CONSOLE EXHIBITED A "LEAKY PILOT VALVE" ALARM AFTER THE PT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) FOLLOWING SURGERY. THE CUSTOMER ALSO REPORTED THAT AFTER A FEW MINUTES, THE ALARM STOPPED. THE CUSTOMER ALSO REPORTED THAT THE PT REMAINED ON THE CSS CONSOLE FOR SEVERAL DAYS UNTIL IT WAS DETERMINED THAT SUPPORT WOULD BE WITHDRAWN. THE CLINICAL STAFF AT THE HOSPITAL CONFIRMED THAT THE FREEDOM DRIVER AND CSS PERFORMED AS INTENDED AND THE PT'S DEATH WAS UNRELATED TO THE TAH-T SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300038 SYNCARDIA CIRCULATORY SUPPORT SYSTEM CONSOLE CIRCULATORY ASSIST DEVICE LOZ SYNCARDIA SYSTEMS, INC. 19

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR