BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA COMPANION 2 DRIVER

    MDR report key: 5171729 · Received October 23, 2015

    Report

    Report Number
    3003761017-2015-00363
    Event Type
    Malfunction
    Date Received
    October 23, 2015
    Date of Event
    October 16, 2015
    Report Date
    October 16, 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

    CE 3010 FOLLOW-UP REPORT 1.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE COMPANION 2 DRIVER EXHIBITED IRREGULAR LEFT DRIVING PRESSURE (LDP) WAVEFORMS WHEN CONNECTED TO THE EXTERNAL WALL AIR WHILE SUPPORTING A PATIENT. THE CUSTOMER ALSO REPORTED THAT THE LDP VARIED FROM 165 TO 255 WHEN IT WAS SET AT 210. THE LDP WAS LESS IRREGULAR AT 205 TO 210 WHEN THE COMPANION 2 DRIVER WAS DISCONNECTED FROM THE EXTERNAL WALL AIR AND THE DRIVER WAS RUNNING ON INTERNAL COMPRESSORS. THE CUSTOMER ALSO REPORTED THAT THE PATIENT WAS SUBSEQUENTLY SWITCHED TO THE BACKUP COMPANION 2 DRIVER. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. THIS ALLEGED FAILURE MODE POSES A LOW RISK TO THE PATIENT BECAUSE ALTHOUGH THE COMPANION 2 DRIVER EXHIBITED IRREGULAR LEFT PRESSURE WAVEFORMS, IT DID 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 INVESTIGATION WILL BE PROVIDED IN A FOLLOW-UP MDR.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE COMPANION 2 DRIVER EXHIBITED IRREGULAR LEFT DRIVING PRESSURE (LDP) WAVEFORMS WHEN CONNECTED TO THE EXTERNAL WALL AIR WHILE SUPPORTING A PATIENT. THE CUSTOMER ALSO REPORTED THAT THE LDP VARIED FROM 165 TO 255 WHEN IT WAS SET AT 210. THE LDP WAS LESS IRREGULAR AT 205 TO 210 WHEN THE COMPANION 2 DRIVER WAS DISCONNECTED FROM THE EXTERNAL WALL AIR AND THE DRIVER WAS RUNNING ON INTERNAL COMPRESSORS. THE CUSTOMER ALSO REPORTED THAT THE PATIENT WAS SUBSEQUENTLY SWITCHED TO THE BACKUP COMPANION 2 DRIVER. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. THE COMPANION 2 DRIVER WAS RETURNED TO SYNCARDIA FOR EVALUATION. VISUAL INSPECTION OF THE DRIVER'S INTERNAL COMPONENTS REVEALED NO ANOMALIES. THE PATIENT FILE WAS COPIED AND REVIEWED, WHICH REVEALED MULTIPLE LEFT PRESSURE INCORRECT ALARMS. REVIEW OF THE PATIENT FILE EXTENDED DATA CONFIRMED THE CUSTOMER-REPORTED FLUCTUATION OF LEFT DRIVELINE PRESSURE READINGS. DURING INVESTIGATION TESTING, THE FLUCTUATION OF THE LEFT DRIVELINE PRESSURE WAS DUPLICATED. THE ROOT CAUSE WAS A MALFUNCTION OF THE LEFT ELECTRONIC PRESSURE REGULATOR. DESPITE THE CUSTOMER-REPORTED FLUCTUATION OF LEFT DRIVELINE PRESSURE READINGS, RISK TO THE PATIENT WAS LOW BECAUSE THE DRIVER CONTINUED TO PERFORM ITS LIFE-SUSTAINING FUNCTIONS. REVIEW OF THE EXTENDED DATA CONFIRMED THAT THE DRIVER DID NOT INDUCE FULL FILLING OF THE VENTRICLES AND THAT FULL EJECTION WAS PRESENT. AFTER THE LEFT ELECTRONIC PRESSURE REGULATOR WAS REPLACED, THE COMPANION 2 DRIVER WAS SERVICED AND PASSED ALL 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
    701442 SYNCARDIA COMPANION 2 DRIVER EXTERNAL PNEUMATIC DRIVER LOZ SYNCARDIA SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR