BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA FREEDOM DRIVER

    MDR report key: 9214166 · Received October 21, 2019

    Report

    Report Number
    3003761017-2019-00306
    Event Type
    Malfunction
    Date Received
    October 21, 2019
    Date of Event
    October 10, 2019
    Report Date
    November 14, 2019
    Manufacturer
    SYNCARDIA SYSTEMS, LLC
    Product Code
    LOZ
    UDI-DI
    00858000003121
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION OF THE DRIVER'S DRIVELINE FOUND NOTABLE DETERIORATION AND DISCOLORATION ON THE METAL OF THE CPC CONNECTOR. THE DISCOLORED SECTION OF METAL COULD NOT BE WIPED OFF THE CPC CONNECTOR. THESE FINDINGS ARE CONSISTENT WITH CORROSION OF METAL. THE DRIVER IN "AS RECEIVED" CONDITION PASSED ALL SECTIONS OF FUNCTIONAL TESTING. THE CUSTOMER-REPORTED ISSUE WAS CONFIRMED DURING THE INVESTIGATION; HOWEVER, THE ROOT CAUSE OF THE CORROSION DAMAGE ON THE CPC CONNECTOR COULD NOT BE CONCLUSIVELY DETERMINED. IT IS POSSIBLE THAT THE CORROSION WAS CAUSED BY FLUID GETTING ON THE CPC CONNECTOR. F-900012-EN, FREEDOM DRIVER SYSTEM OPERATOR MANUAL, SECTION 4.2 STATES "DO NOT SUBMERGE THE FREEDOM DRIVER SYSTEM OR EXPOSE IT TO LIQUID/DEBRIS. PROTECT IT FROM RAIN, SHOWERS, BATHS, AND LIQUID/DEBRIS." IF A DRIVER IS EXPOSED TO LIQUID, F-900012-EN STATES THAT THE DRIVER MUST BE EXCHANGED FOR A BACKUP FREEDOM DRIVER. 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. (B)(4) 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 WILL BE 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 CPC (COLDER PRODUCTS COMPANY) CONNECTOR IS A COMPONENT THAT PROVIDES THE INTERFACE BETWEEN THE DRIVER DRIVELINES AND THE TAH-T CANNULA. THE FREEDOM DRIVER WAS NOT SUPPORTING A PATIENT. THE CUSTOMER, A SYNCARDIA CERTIFIED HOSPITAL, REPORTED THAT THE FREEDOM DRIVER HAD A CORRODED CPC CONNECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1010383 SYNCARDIA FREEDOM DRIVER EXTERNAL PNEUMATIC DRIVER LOZ SYNCARDIA SYSTEMS, LLC 595000-001 00858000003121

    Patients

    Seq Age Sex Outcome Treatment
    1