BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA COMPANION 2 DRIVER

    MDR report key: 7078767 · Received December 4, 2017

    Report

    Report Number
    3003761017-2017-00232
    Event Type
    Malfunction
    Date Received
    December 4, 2017
    Date of Event
    November 9, 2017
    Report Date
    November 9, 2017
    Manufacturer
    SYNCARDIA SYSTEMS, LLC
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ALLEGED FAILURE MODE POSES A LOW RISK TO A PATIENT BECAUSE THE ISSUE WAS OBSERVED WHEN THE COMPANION 2 DRIVER WAS NOT SUPPORTING A PATIENT. THE COMPANION 2 DRIVER WILL BE RETURNED TO SYNCARDIA FOR EVALUATION. THE RESULTS OF THE EVALUATION WILL BE PROVIDED IN A FOLLOW-UP MDR. CE 4040 INITIAL.

    Additional Manufacturer Narrative · 1

    THE COMPANION 2 DRIVER WAS RETURNED TO SYNCARDIA FOR EVALUATION. THE CUSTOMER-REPORTED ISSUE OF AN EMERGENCY BATTERY ERROR ALARM WAS CONFIRMED THROUGH REVIEW OF THE PATIENT AND ALARM HISTORY DATA AND INVESTIGATION TESTING. COMMUNICATION WITH THE EMERGENCY BATTERY COULD NOT BE ESTABLISHED, INDICATING THAT THE EMERGENCY BATTERY WAS BELOW THE CUT-OFF VOLTAGE AND WAS DEEPLY DEPLETED. THE ROOT CAUSE FOR THE DEPLETED EMERGENCY BATTERY COULD NOT BE CONCLUSIVELY DETERMINED BASED UPON THE INFORMATION PROVIDED, HOWEVER, REVIEW OF THE DRIVER DATA INDICATES THAT THE DRIVER WAS STORED AND NOT IN USE FOR AN EXTENDED PERIOD OF TIME BEFORE BEING USED FOR TRAINING. IT IS POSSIBLE THAT DURING THIS PERIOD THE DRIVER WAS NOT PLUGGED INTO SHORE POWER, WHICH WOULD HAVE CAUSED THE EMERGENCY BATTERY TO BECOME DEPLETED. THE COMPANION 2 DRIVER SYSTEM OPERATOR MANUAL (C2-900005) PROVIDES GUIDANCE ON DRIVER STORAGE REQUIREMENTS IN SECTION 12.10, WHICH STATES "ALWAYS STORE COMPANION 2 DRIVERS IN A HOSPITAL CART OR CADDY THAT IS CONNECTED TO EXTERNAL (WALL) POWER." 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. (B)(4) FOLLOW-UP REPORT 1.

    Description of Event or Problem · 1

    THE COMPANION 2 DRIVER WAS NOT SUPPORTING A PATIENT. THE CUSTOMER, A SYNCARDIA CERTIFIED HOSPITAL, REPORTED THAT WHEN THE COMPANION 2 DRIVER WAS TURNED ON FOR A TRAINING SESSION, THE COMPANION EXTERNAL BATTERIES SHOWED 3 LEDS (60% OR LESS) AND THE EMERGENCY BATTERY LIGHT WAS BLINKING. THE CUSTOMER ALSO REPORTED THAT AFTER APPROXIMATELY 30 SECONDS, THE COMPANION 2 DRIVER EXHIBITED AN EMERGENCY BATTERY ERROR ALARM. THE CUSTOMER ALSO REPORTED THAT WHEN THE EXTERNAL BATTERIES WERE REMOVED, THE COMPANION 2 DRIVER POWERED OFF. THE CUSTOMER ALSO REPORTED THAT THE COMPANION 2 DRIVER WAS THEN PLUGGED INTO WALL POWER FOR THE WEEKEND AND WHEN POWERED UP, THE DRIVER EXHIBITED ANOTHER EMERGENCY BATTERY ERROR ALARM.

    Description of Event or Problem · 1

    THE COMPANION 2 DRIVER WAS NOT SUPPORTING A PATIENT. THE CUSTOMER, A SYNCARDIA CERTIFIED HOSPITAL, REPORTED THAT WHEN THE COMPANION 2 DRIVER WAS TURNED ON FOR A TRAINING SESSION, THE COMPANION EXTERNAL BATTERIES SHOWED 3 LEDS (60% OR LESS) AND THE EMERGENCY BATTERY LIGHT WAS BLINKING. THE CUSTOMER ALSO REPORTED THAT AFTER APPROXIMATELY 30 SECONDS, THE COMPANION 2 DRIVER EXHIBITED AN EMERGENCY BATTERY ERROR ALARM. THE CUSTOMER ALSO REPORTED THAT WHEN THE EXTERNAL BATTERIES WERE REMOVED, THE COMPANION 2 DRIVER POWERED OFF. THE CUSTOMER ALSO REPORTED THAT THE COMPANION 2 DRIVER WAS THEN PLUGGED INTO WALL POWER FOR THE WEEKEND AND WHEN POWERED UP, THE DRIVER EXHIBITED ANOTHER EMERGENCY BATTERY ERROR ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860345 SYNCARDIA COMPANION 2 DRIVER EXTERNAL PNEUMATIC DRIVER LOZ SYNCARDIA SYSTEMS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1