BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA FREEDOM DRIVER

    MDR report key: 10950153 · Received December 4, 2020

    Report

    Report Number
    3003761017-2020-00251
    Event Type
    Malfunction
    Date Received
    December 4, 2020
    Date of Event
    November 20, 2020
    Report Date
    April 6, 2021
    Manufacturer
    SYNCARDIA SYSTEMS, LLC
    Product Code
    LOZ
    UDI-DI
    00858000003121
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION OF DRIVER CONFIRMED THE CUSTOMER-REPORTED STRIPPED POTENTIOMETER COVER TORX SCREW. THE ROOT CAUSE OF THE SCREW DAMAGE COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, THIS DAMAGE CAN POSSIBLY OCCUR DUE TO IMPROPER USE (USING THE INCORRECT TOOL TO REMOVE OR INSERT THE SCREW). A SPECIALIZED TOOL, THE L TORX WRENCH WHICH IS DESIGNED TO AVOID THE CENTER TIP ON THE HEAD SCREW, 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. THE LABELING 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 LIKELY THAT THE TORX SCREW WOULD BE DAMAGED WHEN ADJUSTED WITH AN IMPROPER TOOL. THIS ISSUE WILL BE MONITORED AND TRENDED AS PART OF THE CUSTOMER EXPERIENCE PROCESS. SYNCARDIA HAS COMPLETED ITS INVESTIGATION AND IS CLOSING THIS FILE. CE 5426 FOLLOW-UP REPORT 1.

    Additional Manufacturer Narrative · 1

    THE FREEDOM DRIVER WILL BE RETURNED TO SYNCARDIA FOR EVALUATION. THE RESULTS WILL BE PROVIDED IN A FOLLOW-UP MDR. (B)(4) INITIAL.

    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 THE COVER COULD NOT BE REMOVED TO ADJUST THE BEAT RATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1410249 SYNCARDIA FREEDOM DRIVER EXTERNAL PNUEMATIC DRIVER LOZ SYNCARDIA SYSTEMS, LLC 595000-001 00858000003121

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR