BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA COMPANION 2 DRIVER

    MDR report key: 7434442 · Received April 16, 2018

    Report

    Report Number
    3003761017-2018-00106
    Event Type
    Malfunction
    Date Received
    April 16, 2018
    Date of Event
    March 21, 2018
    Report Date
    March 21, 2018
    Manufacturer
    SYNCARDIA SYSTEMS, LLC
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPANION 2 DRIVER WAS RETURNED TO SYNCARDIA FOR EVALUATION. THE CUSTOMER-REPORTED ISSUE WAS CONFIRMED THROUGH REVIEW OF THE DRIVER'S 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. IT IS SUSPECTED THAT THE EMERGENCY BATTERY WAS PERMANENTLY FAULTED. THE ROOT CAUSE OF 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 APPROXIMATELY FOUR MONTHS UNTIL AN EMERGENCY BATTERY ERROR ALARM WAS OBSERVED AND THEN ANOTHER TWO MONTHS BEFORE TWO ADDITIONAL EMERGENCY BATTERY ERROR ALARMS WERE OBSERVED. IT IS POSSIBLE THAT DURING THIS PERIOD THE DRIVER WAS NOT PLUGGED INTO WALL 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.

    Additional Manufacturer Narrative · 0

    THE COMPANION 2 DRIVER WAS RETURNED TO SYNCARDIA FOR EVALUATION. THE CUSTOMER-REPORTED ISSUE WAS CONFIRMED THROUGH REVIEW OF THE DRIVER'S 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. IT IS SUSPECTED THAT THE EMERGENCY BATTERY WAS PERMANENTLY FAULTED. THE ROOT CAUSE OF 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 APPROXIMATELY FOUR MONTHS UNTIL AN EMERGENCY BATTERY ERROR ALARM WAS OBSERVED AND THEN ANOTHER TWO MONTHS BEFORE TWO ADDITIONAL EMERGENCY BATTERY ERROR ALARMS WERE OBSERVED. IT IS POSSIBLE THAT DURING THIS PERIOD THE DRIVER WAS NOT PLUGGED INTO WALL 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 · 0

    THE COMPANION 2 DRIVER WAS NOT SUPPORTING A PATIENT. THE CUSTOMER, A SYNCARDIA CERTIFIED HOSPITAL, REPORTED THAT THE COMPANION 2 DRIVER EXHIBITED AN EMERGENCY BATTERY ALARM DESPITE BEING PLUGGED INTO WALL POWER.

    Description of Event or Problem · 0

    THE COMPANION 2 DRIVER WAS NOT SUPPORTING A PATIENT. THE CUSTOMER, A SYNCARDIA CERTIFIED HOSPITAL, REPORTED THAT THE COMPANION 2 DRIVER EXHIBITED AN EMERGENCY BATTERY ALARM DESPITE BEING PLUGGED INTO WALL POWER.

    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 HAS BEEN RETURNED TO SYNCARDIA FOR EVALUATION. THE RESULTS OF THE EVALUATION WILL BE PROVIDED IN A FOLLOW-UP MDR. (B)(4).

    Description of Event or Problem · 1

    THE COMPANION 2 DRIVER WAS NOT SUPPORTING A PATIENT. THE CUSTOMER, A SYNCARDIA CERTIFIED HOSPITAL, REPORTED THAT THE COMPANION 2 DRIVER EXHIBITED AN EMERGENCY BATTERY ALARM DESPITE BEING PLUGGED INTO WALL POWER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277826 SYNCARDIA COMPANION 2 DRIVER EXTERNAL PNEUMATIC DRIVER LOZ SYNCARDIA SYSTEMS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1