BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNCARDIA CIRCULATORY SUPPORT SYSTEM CONSOLE

    MDR report key: 2872394 · Received December 6, 2012

    Report

    Report Number
    3003761017-2012-00088
    Event Type
    Other
    Date Received
    December 6, 2012
    Date of Event
    November 18, 2012
    Report Date
    December 5, 2012
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED "LEAKY PILOT VALVE" ALARM POSES A LOW RISK TO THE PATIENT, BECAUSE IT DOES NOT PREVENT THE CSS CONSOLE FROM PERFORMING ITS LIFE-SUSTAINING FUNCTIONS. THE CSS CONSOLE HAS TWO CONTROLLERS, AND REDUNDANT SYSTEMS REMAINED AVAILABLE. SYNCARDIA HAS COMPLETED ITS EVALUATION OF THIS COMPLAINT AND IS CLOSING THIS FILE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT CSS CONSOLE #9 WAS DISPLAYING A "LEAKY PILOT VALVE" ALARM WHILE SUPPORTING A PATIENT. THE "LEAKY PILOT VALVE" ALARM IS A KNOWN CSS CONSOLE CALIBRATION ISSUE. A "LEAKY PILOT VALVE" ALARM IS USUALLY REMEDIED BY ADJUSTED THE CONTROLLER'S PILOT VALVE REGULATOR. THIS ADJUSTMENT WAS PERFORMED BY THE CUSTOMER AND RESOLVED THE ISSUE, BUT THE ALARM HAD OCCURRED SEVERAL TIMES. THE PATIENT WAS SWITCHED TO A BACKUP CSS CONSOLE, AND CSS CONSOLE #9 WAS RETURNED TO SYNCARDIA FOR EVALUATION. THERE WAS NO PATIENT IMPACT. UPON ARRIVAL OF CSS CONSOLE #9 AT SYNCARDIA, THE CSS CONSOLE DID NOT EXHIBIT THE REPORTED "LEAKY PILOT VALVE" ALARM AND PASSED THE CONSOLE TEST VALIDATION PROTOCOL. THE HUMPHREY (MAIN) VALVES AND THE CLIPPARD (PILOT) VALVES WERE REMOVED, CLEANED, AND REINSTALLED. THE CONSOLE WAS THEN RECALIBRATED TO ENSURE THAT IT PERFORMED AS INTENDED, AND THE CONSOLE PASSED THE CONSOLE TEST VALIDATION PROTOCOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCARDIA CIRCULATORY SUPPORT SYSTEM CONSOLE CIRCULATORY ASSIST DEVICE LOZ SYNCARDIA SYSTEMS, INC. CSS CONSOLE 9

    Patients

    Seq Age Sex Outcome Treatment
    1