BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA FREEDOM DRIVER

    MDR report key: 8503874 · Received April 11, 2019

    Report

    Report Number
    3003761017-2019-00064
    Event Type
    Malfunction
    Date Received
    April 11, 2019
    Date of Event
    March 15, 2019
    Report Date
    April 25, 2019
    Manufacturer
    SYNCARDIA SYSTEMS, LLC
    Product Code
    LOZ
    UDI-DI
    00858000003008
    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

    FROM (B)(6) 2016 TO (B)(6) 2019. DETACHMENT OR DISCONNECTION OF DRIVELINES FROM TAH-T CANNULAE IS ADDRESSED IN RA-483, TAH-T DESIGN FAILURE MODES AND EFFECTS ANALYSIS AND RA-136, FREEDOM® DRIVER SYSTEM APPLICATIONS FAILURE MODES AND EFFECTS ANALYSIS (FMEA). MITIGATING ACTION FOR THIS ISSUE INCLUDES WIRE TIES APPLIED AROUND THE BARBED PORTION OF THE CPC CONNECTORS. IT WAS REPORTED BY THE CUSTOMER THAT THE WIRE TIES USED TO PREVENT ACCIDENTAL DISCONNECTION WERE IN PLACE AT THE TIME OF THE REPORTED ISSUE. AFTER THE OCCURRENCE OF THE REPORTED ISSUE, THE CUSTOMER REPORTED THAT THE VAD COORDINATOR ASSESSED THE CPC CONNECTORS AND DID NOT SEE ANY ISSUE WITH THE CONNECTION. PER F-900013-EN, FREEDOM DRIVER SYSTEM OPERATOR MANUAL - US, CLINICIANS AND PATIENTS ARE TRAINED TO SECURE THE CPC CONNECTOR IN THE CANNULA AND DRIVELINE TUBING USING AT LEAST TWO WIRE TIES AND TO THREAD A WIRE TIE BENEATH THE THUMB RELEASE TAB OF THE CPC CONNECTORS TO PREVENT ACCIDENTAL DISCONNECTION OF EITHER LOCATION. THE CUSTOMER REPORTED THAT ZIP TIES WERE IN PLACE AND THE PATIENT'S WIFE WAS ABLE TO RECONNECT THE CANNULA. 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 4714 FOLLOW-UP REPORT 1.

    Additional Manufacturer Narrative · 1

    THE 70CC TAH-T REMAINS IMPLANTED AND THE FREEDOM DRIVER CONTINUES TO SUPPORT THE PATIENT. THE RESULTS OF THE INVESTIGATION WILL BE PROVIDED IN A FOLLOWUP 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 CUSTOMER, A SYNCARDIA CERTIFIED HOSPITAL, REPORTED THAT THE PATIENT MISSED A STEP GOING UP THE STAIRS AT HIS HOME, STEPPED ON THE FREEDOM DRIVER DRIVELINES WHICH RESULTED IN THE CANNULA BEING DISCONNECTED AT THE CPC CONNECTOR. THE CUSTOMER ALSO REPORTED THAT THE PATIENT'S WIFE RECONNECTED THE CANNULA. THE CUSTOMER ALSO REPORTED THAT THE PATIENT FELT "WOOZINESS FOR A FEW SECONDS" BUT NEVER LOST CONSCIOUSNESS. THE CUSTOMER ALSO REPORTED THAT ON A SUBSEQUENT HOSPITAL VISIT, THE CONNECTIONS WERE ASSESSED AND EVERYTHING APPEARED TIGHT. THE PATIENT REMAINS SUPPORTED BY THE FREEDOM DRIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295651 SYNCARDIA FREEDOM DRIVER EXTERNAL PNEUMATIC DRIVER LOZ SYNCARDIA SYSTEMS, LLC 500101-001 116749 00858000003008

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR