BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA COMPANION 2 DRIVER

    MDR report key: 5171725 · Received October 23, 2015

    Report

    Report Number
    3003761017-2015-00361
    Event Type
    Malfunction
    Date Received
    October 23, 2015
    Date of Event
    October 14, 2015
    Report Date
    October 14, 2015
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 SUPPORTING A PATIENT. THE CUSTOMER REPORTED THAT THE COMPANION 2 DRIVER EXHIBITED AN INTERNAL EMERGENCY BATTERY ERROR ALARM DESPITE BEING CONNECTED TO THE EXTERNAL WALL POWER FOR SEVERAL DAYS. THE CUSTOMER ALSO REPORTED THAT WHILE THE COMPANION 2 DRIVER IS DISCONNECTED TO THE EXTERNAL WALL POWER AND THE EXTERNAL BATTERIES ARE REMOVED, THE DRIVER INSTANTLY TURNS OFF, DISPLAYS A WHITE SCREEN, AND EXHIBITS A HIGH TONE ALARM. 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 INVESTIGATION WILL BE PROVIDED IN A FOLLOW-UP MDR.

    Description of Event or Problem · 1

    THE COMPANION 2 DRIVER WAS NOT SUPPORTING A PATIENT. THE CUSTOMER REPORTED THAT THE COMPANION 2 DRIVER EXHIBITED AN INTERNAL EMERGENCY BATTERY ERROR ALARM DESPITE BEING CONNECTED TO THE EXTERNAL WALL POWER FOR SEVERAL DAYS. THE CUSTOMER ALSO REPORTED THAT WHILE THE COMPANION 2 DRIVER IS DISCONNECTED TO THE EXTERNAL WALL POWER AND THE EXTERNAL BATTERIES ARE REMOVED, THE DRIVER INSTANTLY TURNS OFF, DISPLAYS A WHITE SCREEN, AND EXHIBITS A HIGH TONE ALARM. THE COMPANION 2 DRIVER WAS RETURNED TO SYNCARDIA FOR EVALUATION. THE PATIENT FILE WAS COPIED AND REVIEWED, REVEALING MULTIPLE EMERGENCY BATTERY ERROR ALARMS. THE CUSTOMER-REPORTED ISSUE WAS CONFIRMED. DURING INVESTIGATION TESTING, EFFORTS TO REPRODUCE THE EMERGENCY BATTERY ERROR ALARMS WERE SUCCESSFUL. A REVIEW OF THE EMERGENCY BATTERY'S HISTORY EVENT DATA REVEALED A PERMANENT FAULT, A CELL UNDER VOLTAGE (CUV) FLAG, AND A PACK UNDER VOLTAGE (PUV) FLAGS. THE CUV AND PUV FLAGS INDICATE THAT THE EMERGENCY BATTERY WAS DEPLETED AND UNRECOVERABLE. THE COMPANION 2 DRIVER WAS NOT SUPPORTING A PATIENT AT THE TIME OF THE CUSTOMER-REPORTED ISSUE AND THEREFORE, THERE WAS NO PATIENT IMPACT. HOWEVER, HAD THE DRIVER BEEN SUPPORTING A PATIENT, AN EMERGENCY BATTERY ERROR ALARM WOULD POSE A LOW RISK TO A PATIENT BECAUSE THE DRIVER WOULD HAVE CONTINUED TO PERFORM ITS LIFE-SUSTAINING FUNCTIONS. THE EMERGENCY BATTERY IS ONE OF FOUR REDUNDANT POWER SOURCES AND IS DESIGNED TO BE USED ONLY IN THE EVENT THAT AC POWER AND THE TWO EXTERNAL BATTERIES HAVE BEEN REMOVED FROM THE DRIVER. THE COMPANION 2 DRIVER SYSTEM OPERATOR MANUAL - ENGLISH OUS, SECTION 12.10, STATES THAT THE DRIVER SHOULD ALWAYS BE CONNECTED TO AN ACTIVE WALL OUTLET AT ANY TIME IN ORDER TO CONSERVE BATTERY POWER. IN ADDITION, THE OPERATOR MANUAL INSTRUCTS HOSPITAL PERSONNEL TO COMPLETE THE COMPANION 2 DRIVER SYSTEM CHECK UPON RECEIPT, PRIOR TO USE, AND EVERY SIX MONTHS IF THE DRIVER IS NOT IN USE. THE SYSTEM CHECK VERIFIES THAT THE DRIVER RUNS ON THE EMERGENCY BATTERY AND THAT THE DISPLAY AND AUDIBLE ALARMS ARE FUNCTIONING. THE EMERGENCY BATTERY WAS REPLACED AND DISPOSITIONED. THE COMPANION 2 DRIVER WAS SERVICED AND PASSED ALL FUNCTIONAL AND PERFORMANCE TESTING BEFORE BEING PLACED INTO FINISHED GOODS. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701270 SYNCARDIA COMPANION 2 DRIVER EXTERNAL PNEUMATIC DRIVER LOZ SYNCARDIA SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1