BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNCARDIA COMPANION 2 DRIVER

    MDR report key: 3457843 · Received October 30, 2013

    Report

    Report Number
    3003761017-2013-00117
    Event Type
    Other
    Date Received
    October 30, 2013
    Date of Event
    October 6, 2013
    Report Date
    October 31, 2013
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANION 2 DRIVER WAS RETURNED TO SYNCARDIA FOR EVALUATION. THE ELECTRONIC PATIENT FILE WAS REVIEWED BY A SYNCARDIA CONSULTING FIRM USED FOR SOFTWARE DATA ANALYSIS. THE RESULTS FROM THE ELECTRONIC PATIENT REVIEW CONCLUDED THAT AT THAT TIME THE "SYSTEM MALFUNCTION" ALARM OCCURRED, THE KEY SWITCH OF THE DRIVER WAS PARTIALLY MOVED TO THE OFF POSITION. THE RESULT OF THIS ACTION WAS AN INTERNAL SHUTDOWN SIGNAL WHICH WAS SENT TO THE RIGHT EMBEDDED SUPERVISOR, BEGINNING THE SHUTDOWN PROCESS. FIVE SECONDS LATER, THE RIGHT EMBEDDED SUPERVISOR RECORDED A FAULT, SIGNIFYING THAT THE LEFT EMBEDDED SUPERVISOR DID NOT AGREE THAT THIS WAS A VALID SHUTDOWN SIGNAL. THIS WAS REPORTED TO THE SINGLE BOARD COMPUTER AS A SUPERVISOR FAILURE, RESULTING IN THE DISPLAY OF THE "SYSTEM MALFUNCTION" ALARM. THE ELECTRONIC PATIENT FILE ALSO RECORDED THAT 100 SECONDS LATER, THE KEY SWITCH WAS MOVED COMPLETELY TO THE OFF POSITION, AT WHICH TIME BOTH THE LEFT AND RIGHT EMBEDDED SUPERVISORS AGREED TO THE SHUTDOWN AND SUBSEQUENTLY SHUT DOWN THE DRIVER. IF THE DRIVER IS FUNCTIONING AS INTENDED, THE DRIVER WILL ONLY SHUT DOWN WHEN THE KEY IS IN THE OFF POSITION. THE DRIVER PASSED ALL PERFORMANCE TESTING AND CONTINUED TO RUN IN THE LAB AT SYNCARDIA FOR (B)(4) HOURS WITH NO ALARMS OBSERVED. ADDITIONAL TESTING WAS PERFORMED TO DETERMINE IF ACCIDENTAL CONTACT WITH THE KEY WOULD FORCE THE KEY INTO THE OFF POSITION. THE KEY WAS SET ON THE ON POSITION AND WAS JOSTLED AND TAPPED, BUT THE KEY DID NOT MOVE PARTIALLY OR COMPLETELY TO THE OFF POSITION. IN AN ATTEMPT TO REPRODUCE THE "SYSTEM MALFUNCTION" ALARM, THE KEY SWITCH WAS PARTIALLY TURNED TO THE OFF POSITION, AND APPROXIMATELY FIVE SECONDS LATER, A "SYSTEM MALFUNCTION" ALARM OCCURRED. A VISUAL INSPECTION OF THE DRIVER'S INTERNAL COMPONENTS REVEALED NO ANOMALIES. THE KEY SWITCH ASSEMBLY WAS PROPERLY CONNECTED TO THE POWER MANAGEMENT PRINTED CIRCUIT ASSEMBLY AND TURNED ON AND OFF AS INTENDED. THE ROOT CAUSE OF THE "SYSTEM MALFUNCTION" ALARM WAS THAT THE KEY WAS PARTIALLY IN THE OFF POSITION. THE ROOT CAUSE OF THE DRIVER SHUTDOWN WAS THAT THE KEY WAS PLACED INTO THE OFF POSITION AFTER THE "SYSTEM MALFUNCTION" ALARM OCCURRED. THE APPROPRIATE HOSPITAL STAFF HAVE BEEN RETRAINED ON THE USE OF THE COMPANION 2 DRIVER SYSTEM. SYNCARDIA HAS COMPLETED ITS EVALUATION OF THIS COMPLAINT AND IS CLOSING THIS FILE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE COMPANION 2 DRIVER, WHICH WAS SUPPORTING A PATIENT, EXHIBITED A "SYSTEM MALFUNCTION" ALARM AND THEN REPORTEDLY SHUT DOWN. THE CUSTOMER ALSO REPORTED THAT THE PATIENT WAS SUPPORTED BY A SYNCARDIA HAND PUMP UNTIL AN EXCHANGE WAS MADE TO A BACKUP COMPANION 2 DRIVER. THERE WAS NO ADVERSE PATIENT IMPACT. ADDITIONAL INFORMATION WAS PROVIDED TO SYNCARDIA BY THE PATIENT'S WIFE, WHO REPORTED THAT SHE OBSERVED A SHUTDOWN MESSAGE ON THE DRIVER DISPLAY. SHE ALSO REPORTED THAT THE KEY WAS STILL INSERTED IN THE KEY SWITCH WHEN THE SHUTDOWN OCCURRED. A SYNCARDIA CLINICAL SUPPORT SPECIALIST INSPECTED THE COMPANION 2 DRIVER THE NEXT DAY AND VERIFIED THAT THE KEY WAS STILL INSERTED IN THE KEY SWITCH AND WAS IN THE OFF POSITION. THE CUSTOMER STATED THAT THE DRIVER WAS NOT MANIPULATED IN ANY WAY AFTER THE DRIVER SHUTDOWN. THE "COMPANION 2 DRIVER SYSTEM OPERATOR MANUAL" AT CHAPTER 6, SECTION 6.3, PARAGRAPH 5 PROVIDES SPECIFIC INSTRUCTION TO THE USER TO REMOVE THE KEY AFTER THE COMPANION 2 DRIVER IS TURNED ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556721 SYNCARDIA COMPANION 2 DRIVER CIRCULATORY ASSIST DEVICE LOZ SYNCARDIA SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR