BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA FREEDOM DRIVER

    MDR report key: 4939763 · Received July 20, 2015

    Report

    Report Number
    3003761017-2015-00227
    Event Type
    Malfunction
    Date Received
    July 20, 2015
    Date of Event
    July 9, 2015
    Report Date
    July 9, 2015
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    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

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE FREEDOM DRIVER EXHIBITED A FAULT ALARM WHILE SUPPORTING A PATIENT AT HOME. THE CUSTOMER ALSO REPORTED THAT THE PATIENT SWITCHED TO THE BACKUP FREEDOM DRIVER WITHOUT ANY PATIENT IMPACT. THE FREEDOM DRIVER WAS RETURNED TO SYNCARDIA FOR EVALUATION. VISUAL INSPECTION OF THE DRIVER'S EXTERNAL AND INTERNAL COMPONENTS REVEALED NO ABNORMALITIES. DURING TESTING, THE DRIVER EXHIBITED A FAULT ALARM IMMEDIATELY UPON STARTUP, BUT PASSED ALL PRESSURE TEST REQUIREMENTS, WHICH INCLUDED CARDIAC OUTPUT, RAP (RIGHT ATRIAL PRESSURE), AOP (AORTIC PRESSURE), PAP (PULMONARY ARTERIAL PRESSURE) AND LAP (LEFT ATRIAL PRESSURE) PERFORMANCE REQUIREMENTS ASSOCIATED WITH NOMINAL NORMOTENSIVE AND HYPERTENSIVE SETTINGS. THE CUSTOMER-REPORTED FAULT ALARM WAS REPRODUCED. THE ROOT CAUSE FOR THE CUSTOMER REPORTED FAULT ALARM WAS CORROSION OF THE INTERNAL BOND WIRES WITHIN THE PRESSURE SENSOR (U22) ON THE MAIN PCBA. THIS CORROSION OF THE U22 BOND WIRES IS CONSISTENT WITH OBSERVATIONS MADE IN A CAPA (CORRECTIVE OR PREVENTIVE ACTION) TO ADDRESS THE U22 PRESSURE SENSOR FAILURES. THE CAPA WILL DOCUMENT THE INVESTIGATION INCLUDING, BUT NOT LIMITED TO, POTENTIAL ROOT CAUSE AND CORRECTIVE ACTIONS ASSOCIATED WITH U22 PRESSURE SENSOR FAILURE EVENTS. THIS FAILURE MODE POSES A LOW RISK TO THE PATIENT BECAUSE IT DID NOT PREVENT THE DRIVER FROM PERFORMING ITS LIFE-SUSTAINING FUNCTIONS. THE DRIVER WAS SERVICED, WHICH INCLUDED THE REPLACEMENT OF THE MAIN PCBA, 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE FREEDOM DRIVER EXHIBITED A FAULT ALARM WHILE SUPPORTING A PATIENT AT HOME. THE CUSTOMER ALSO REPORTED THAT THE PATIENT SWITCHED TO THE BACKUP FREEDOM DRIVER WITHOUT ANY PATIENT IMPACT. THIS ALLEGED FAILURE MODE POSES A LOW RISK TO THE PATIENT BECAUSE IT DOES NOT PREVENT THE FREEDOM DRIVER FROM PERFORMING ITS LIFE-SUSTAINING FUNCTIONS. THE FREEDOM DRIVER WILL BE RETURNED TO SYNCARDIA FOR EVAL. THE RESULTS OF THE INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTAL MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470359 SYNCARDIA FREEDOM DRIVER EXTERNAL PNEUMATIC DRIVER LOZ SYNCARDIA SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR