BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA FREEDOM DRIVER

    MDR report key: 7121652 · Received December 15, 2017

    Report

    Report Number
    3003761017-2017-00254
    Event Type
    Malfunction
    Date Received
    December 15, 2017
    Date of Event
    December 8, 2017
    Report Date
    June 18, 2018
    Manufacturer
    SYNCARDIA SYSTEMS, LLC
    Product Code
    LOZ
    UDI-DI
    00858000003121
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE DRIVER IN "AS RECEIVED" CONDITION PASSED ALL TEST REQUIREMENTS AND PRESSURE PERFORMANCE METRICS ASSOCIATED WITH NORMOTENSIVE AND HYPERTENSIVE SETTINGS. THE DRIVER'S ALARM HISTORY WAS REVIEWED AND REVEALED FOUR ALARM CODES. WHILE IT CANNOT BE CONCLUSIVELY DETERMINED WHAT CAUSED EACH OF THE RECORDED ALARMS, THE CUSTOMER-REPORTED FAULT ALARMS COULD NOT BE REPRODUCED DURING INVESTIGATION TESTING. THE DRIVER FUNCTIONED AS INTENDED WITH NO EVIDENCE OF A DEVICE MALFUNCTION. THIS ISSUE WILL CONTINUE TO BE MONITORED AND TRENDED AS PART OF THE CUSTOMER EXPERIENCE PROCESS. SYNCARDIA HAS COMPLETED ITS EVALUATION AND IS CLOSING THIS FILE. (B)(4) FOLLOW-UP REPORT 1.

    Additional Manufacturer Narrative · 1

    THIS ALLEGED FAILURE MODE POSES A LOW RISK TO THE PATIENT BECAUSE ALTHOUGH THE FREEDOM DRIVER EXHIBITED A FAULT ALARM, IT CONTINUED TO PERFORM ITS LIFE-SUSTAINING FUNCTIONS. THE FREEDOM DRIVER WILL BE RETURNED TO SYNCARDIA FOR EVALUATION. THE RESULTS OF THE INVESTIGATION WILL BE PROVIDED IN A FOLLOW-UP MDR. (B)(4). INITIAL.

    Description of Event or Problem · 1

    THE CUSTOMER, A SYNCARDIA CERTIFIED HOSPITAL, REPORTED THAT THE FREEDOM DRIVER EXHIBITED INTERMITTENT ALARMS AFTER THE PATIENT RETURNED INDOORS FROM PLAYING BASKETBALL (OUTSIDE TEMPERATURE APPROXIMATELY 20F). THE CUSTOMER ALSO REPORTED THAT THE PATIENT HAD ELEVATED FILL VOLUMES AND CARDIAC OUTPUT WITH NO SYMPTOMS OR COMPLAINTS OF NOT FEELING WELL. THE CUSTOMER ALSO REPORTED THAT AFTER SOMETIME THE FREEDOM DRIVER EXHIBITED A PERMANENT FAULT ALARM. THE CUSTOMER ALSO REPORTED THAT THE PATIENT WAS SWITCHED TO A BACK-UP FREEDOM DRIVER WITHOUT ANY REPORTED ADVERSE PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    903123 SYNCARDIA FREEDOM DRIVER EXTERNAL PNEUMATIC DRIVER LOZ SYNCARDIA SYSTEMS, LLC 595000-001 00858000003121

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR