BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA COMPANION 2 DRIVER

    MDR report key: 5039256 · Received August 28, 2015

    Report

    Report Number
    3003761017-2015-00266
    Event Type
    Malfunction
    Date Received
    August 28, 2015
    Date of Event
    August 20, 2015
    Report Date
    August 20, 2015
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE COMPANION 2 DRIVER WAS NOT IN USE BY A PATIENT. THE CUSTOMER REPORTED THAT THE COMPANION 2 DRIVER HAD A "SYSTEM MALFUNCTION" ALARM WHEN THE DRIVER WAS TURNED ON. COMPANION 2 DRIVER S/N (B)(4) WAS RETURNED TO SYNCARDIA FOR EVALUATION. A REVIEW OF THE DRIVER'S ELECTRONIC PATIENT FILE REVEALED MULTIPLE "SYSTEM MALFUNCTION" ALARMS WITH A TRIGGER VALUE OF MAIN TANK OVERPRESSURE. THESE WERE FOUND TO BE OCCURRING AT SYSTEM STARTUP WHILE EXTERNAL AIR WAS CONNECTED. PER (B)(4), SYNCARDIA COMPANION 2 DRIVER SYSTEM SOFTWARE REQUIREMENTS SPECIFICATION, "IF THE MAIN TANK PRESSURE IS GREATER THAN 13.0 PSI FOR 30 SECONDS, THEN A SYSTEM MALFUNCTION ALARM SHALL BE TRIGGERED." TESTING WAS PERFORMED TO DUPLICATE THE "SYSTEM MALFUNCTION" ALARM AND COULD ONLY BE REPRODUCED UNDER THE CUSTOMER REPORTED CONDITIONS WITH THE ORANGE SHIPPING CAPS INSTALLED. UNDER NORMAL OPERATING CONDITIONS, WITH DRIVELINES CONNECTED, THIS ALARM COULD NOT BE REPRODUCED. THE MANUAL PRESSURE REGULATOR, WHICH REGULATES THE MAIN TANK PRESSURE, WAS EVALUATED AND WAS FOUND TO BE FUNCTIONING PROPERLY. THIS DEDUCED THAT THE CAUSE OF THE "SYSTEM MALFUNCTION" ALARMS WAS A RESULT OF THE DRIVER STARTING UP WITH EXTERNAL AIR INSTALLED AND THE ORANGE SHIPPING CAPS IN PLACE INSTEAD OF THE DRIVELINES. RISK TO THE PATIENT WAS LOW BECAUSE THE DRIVER WAS NOT SUPPORTING A PATIENT AT THE TIME OF THE CUSTOMER REPORTED ISSUE. THEREFORE, THERE WAS NO PATIENT IMPACT. IF THE DRIVER WAS IN PATIENT USE, WITH THE DRIVELINES, THE DRIVER WOULD HAVE PROVIDES 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 COMPANION 2 DRIVER WAS NOT IN USE BY A PATIENT. THE CUSTOMER REPORTED THAT THE COMPANION 2 DRIVER HAD A SYSTEM MALFUNCTION ALARM WHEN THE DRIVER WAS TURNED ON. THIS ALLEGED FAILURE POSES LOW RISK TO A PATIENT BECAUSE THE DRIVER WAS NOT IN PATIENT USE. IN ADDITION, IT WOULD NOT PREVENT THE DRIVER FROM PERFORMING ITS LIFE-SUSTAINING FUNCTIONS. THE COMPANION 2 DRIVER WILL BE RETURNED TO SYNCARDIA FOR EVALUATION. THE RESULTS OF THE EVALUATION WILL BE PROVIDED IN A FOLLOW-UP MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573275 SYNCARDIA COMPANION 2 DRIVER EXTERNAL PNEUMATIC DRIVER LOZ SYNCARDIA SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1