BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA CIRCULATORY SUPPORT SYSTEM CONSOLE

    MDR report key: 1220809 · Received October 30, 2008

    Report

    Report Number
    3003761017-2008-00032
    Event Type
    Malfunction
    Date Received
    October 30, 2008
    Date of Event
    October 21, 2008
    Report Date
    October 29, 2008
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE CSS CONSOLE'S DEVICE HISTORY RECORD WAS CONDUCTED AND REVEALED THAT THE CSS CONSOLE WAS SERVICED IN 2008. NO ISSUES REGARDING THE "PRIMARY TANK LOW PRESSURE" INDICATOR LIGHT LENS WERE REPORTED PRIOR TO OR DURING SERVICING. THE CSS CONSOLE PASSED ALL PRODUCTION AND QUALITY TESTING PRIOR TO RELEASE IN 2008. THE CONSOLE TEST VALIDATION PROTOCOL INCLUDES VERIFICATION THAT THE "PRIMARY TANK LOW PRESSURE" INDICATOR LIGHT LENS DISPLAYS PROPER FUNCTION AND WOULD IDENTIFY A MISSING LENS. A COMPREHENSIVE REVIEW OF ALL COMPLAINTS RECEIVED BY SYNCARDIA FROM THE DATE OF FDA APPROVAL (OCTOBER 15, 2004) TO THE PRESENT HAS REVEALED ONE OTHER INSTANCE OF AN ALARM LIGHT LENS CAP DISENGAGING FROM AN INDICATOR LIGHT, WHICH OCCURRED IN GERMANY ON A DIFFERENT CSS CONSOLE. SYNCARDIA WILL CONTINUE TO MONITOR AND TREND COMPLAINTS ASSOCIATED WITH ALARM LIGHT LENS CAPS. THIS ALLEGED FAILURE MODE HAS NO IMPACT ON THE PT, BECAUSE IT DOES NOT PREVENT THE CSS CONSOLE FROM PERFORMING ITS LIFE-SUSTAINING FUNCTIONS. THE FUNCTIONALITY OF THE VISUAL ALARM LIGHT AND AUDIBLE ALARMS WAS NOT AFFECTED. SYNCARDIA HAS COMPLETED ITS EVALUATION OF THIS COMPLAINT AND IS CLOSING THIS FILE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT HE NOTICED THAT THE YELLOW LENS CAP TO THE "PRIMARY TANK LOW PRESSURE" ALARM INDICATOR ON THE CSS CONSOLE ALARM PANEL WAS MISSING. THE LIGHT BULB WAS STILL IN PLACE. THERE WAS NO PT IMPACT. THIS ALLEGED FAILURE MODE HAS NO IMPACT ON THE PT, BECAUSE IT DOES NOT PREVENT THE CSS CONSOLE FROM PERFORMING ITS LIFE-SUSTAINING FUNCTIONS. THE FUNCTIONALITY OF THE VISUAL ALARM LIGHT AND AUDIBLE ALARMS WAS NOT AFFECTED. INFORMATION SUPPLIED BY THE CUSTOMER INDICATED THAT THE LENS CAP HAD BEEN KNOCKED OFF AND COULD NOT BE LOCATED. A REPLACEMENT LENS CAP WAS SENT TO THE CUSTOMER AND WAS SUCCESSFULLY INSTALLED ON THE ALARM INDICATOR. THE MOST LIKELY CAUSE OF THE LENS CAP DISENGAGING FROM THE "PRIMARY TANK LOW PRESSURE" ALARM INDICATOR IS FORCE THAT WAS APPLIED TO THE FRONT OF THE CSS CONSOLE AT THE ALARM PANEL (SEE APPENDIX 1). BASED UPON THE INFORMATION SUPPLIED BY THE CUSTOMER, IT IS NOT POSSIBLE TO DETERMINE WHAT CAUSED THE IMPACT OR FORCE TO THE ALARM PANEL.

    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 2

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR