BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA FREEDOM DRIVER

    MDR report key: 8593383 · Received May 8, 2019

    Report

    Report Number
    3003761017-2019-00087
    Event Type
    Malfunction
    Date Received
    May 8, 2019
    Date of Event
    April 11, 2019
    Report Date
    July 8, 2019
    Manufacturer
    SYNCARDIA SYSTEMS, LLC
    Product Code
    LOZ
    UDI-DI
    00858000003121
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION CONFIRMED THE CUSTOMER-REPORTED ISSUE OF A DAMAGED POTENTIOMETER COVER TORX SCREW. THE ROOT CAUSE OF THE DAMAGED POTENTIOMETER COVER TORX SCREW CANNOT BE CONCLUSIVELY DETERMINED BUT IS LIKELY DUE TO IMPROPER USE (INCORRECT TOOL TO REMOVE OR INSERT THE SCREW). A SPECIALIZED TOOL, THE L TORX WRENCH, IS PROVIDED WITH THE FREEDOM DRIVER TOOLKIT TO REMOVE AND SCREW IN THE POTENTIOMETER COVER TORX SCREW. F-900013-EN, FREEDOM DRIVER SYSTEM OPERATOR MANUAL FOR US, DESCRIBES INSTRUCTIONS FOR ADJUSTING THE BEAT RATE OF THE FREEDOM DRIVER IN SECTION 7.7. LABELLING STATES, "UNSCREW THE SETTING DIAL COVER ON THE BACK OF THE DRIVER BY USING THE L TORX WRENCH." IF THIS TOOL WAS NOT USED TO INSERT OR REMOVE THE SCREW, IT IS VERY LIKELY THAT THE TORX SCREW WOULD BE DAMAGED WHEN ADJUSTED WITH AN IMPROPER TOOL. DESPITE THE OBSERVED DAMAGE, THE DRIVER PASSED ALL SECTIONS OF FUNCTIONAL TESTING. 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. CE 4744 FOLLOW-UP REPORT 1.

    Additional Manufacturer Narrative · 1

    THIS ALLEGED FAILURE MODE POSES A LOW RISK TO A PATIENT BECAUSE THE ISSUE WAS OBSERVED WHEN THE FREEDOM DRIVER WAS NOT SUPPORTING A PATIENT. THE FREEDOM DRIVER HAS BEEN RETURNED TO SYNCARDIA FOR EVALUATION. THE RESULTS OF THE INVESTIGATION WILL BE PROVIDED IN A FOLLOW-UP MDR. (B)(4).

    Description of Event or Problem · 1

    THE FREEDOM DRIVER WAS NOT SUPPORTING A PATIENT. THE CUSTOMER, A SYNCARDIA CERTIFIED HOSPITAL, REPORTED THAT THE SCREW HEAD ON THE FREEDOM DRIVER BEAT RATE COVER SCREW WAS STRIPPED AND COULD NOT BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383747 SYNCARDIA FREEDOM DRIVER EXTERNAL PNEUMATIC DRIVER LOZ SYNCARDIA SYSTEMS, LLC 595000-001 00858000003121

    Patients

    Seq Age Sex Outcome Treatment
    1