BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA FREEDOM DRIVER

    MDR report key: 8621135 · Received May 17, 2019

    Report

    Report Number
    3003761017-2019-00156
    Event Type
    Malfunction
    Date Received
    May 17, 2019
    Date of Event
    May 1, 2019
    Report Date
    September 13, 2019
    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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER-REPORTED AIR LEAK WAS NOT ABLE TO BE CONFIRMED OR REPRODUCED WITH THE FREEDOM DRIVER AND ITS DRIVELINES. THE FREEDOM DRIVER PASSED ALL SECTIONS OF FUNCTIONAL TESTING. ADDITIONALLY, AN AIR LEAK TEST WAS PERFORMED ON THE DRIVELINES, INCLUDING THE CPC CONNECTORS, AND NO LEAKS WERE OBSERVED. 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 THE PATIENT BECAUSE ALTHOUGH THE REPORTED ISSUE WAS OBSERVED WHEN THE FREEDOM DRIVER WAS SUPPORTING A PATIENT, THE FREEDOM DRIVER CONTINUED TO PERFORM ITS LIFE-SUSTAINING FUNCTIONS. 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 REPORTED ISSUE INVOLVES THE FOLLOWING SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM COMPONENTS AND ARE REPORTED UNDER TWO SEPARATE MEDICAL DEVICE REPORTS: (1) FREEDOM DRIVER S/N (B)(4) (MFR REPORT # 3003761017-2019-00156) AND (2) FREEDOM DRIVER S/N (B)(4) (MFR REPORT # 3003761017-2019-00157). THE CPC (COLDER PRODUCTS COMPANY) CONNECTOR IS A COMPONENT THAT PROVIDES THE INTERFACE BETWEEN THE DRIVER DRIVELINES AND THE TAH-T CANNULA. THE CUSTOMER, A SYNCARDIA CERTIFIED HOSPITAL, REPORTED THAT THE RED CPC CONNECTOR ON FREEDOM DRIVER S/N (B)(4) HAD AN AIR LEAK WHILE SUPPORTING A PATIENT. THE PATIENT WAS SWITCHED TO A BACK-UP DRIVER. THE CUSTOMER, A SYNCARDIA CERTIFIED HOSPITAL, ALSO REPORTED THAT THE BLUE CPC CONNECTOR ON FREEDOM DRIVER S/N (B)(4) HAD AN AIR LEAK WHILE SUPPORTING A PATIENT. THE PATIENT WAS SWITCHED TO A BACK-UP DRIVER. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414687 SYNCARDIA FREEDOM DRIVER EXTERNAL PNEUMATIC DRIVER LOZ SYNCARDIA SYSTEMS, LLC 595000-001 00858000003121

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR