BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA FREEDOM DRIVER

    MDR report key: 7084350 · Received December 5, 2017

    Report

    Report Number
    3003761017-2017-00243
    Event Type
    Malfunction
    Date Received
    December 5, 2017
    Date of Event
    November 18, 2017
    Report Date
    November 18, 2017
    Manufacturer
    SYNCARDIA SYSTEMS, LLC
    Product Code
    LOZ
    UDI-DI
    00858000003121
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FREEDOM DRIVER WAS RETURNED TO SYNCARDIA FOR EVALUATION. THE DRIVER DID NOT PASS THE PRESSURE RELATED SECTIONS OF EVALUATION TESTING AND THE CUSTOMER-REPORTED ISSUE WAS REPRODUCED. THE ROOT CAUSE WAS DETERMINED TO BE A MALFUNCTION OF THE PISTON AND CYLINDER ASSEMBLY. 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.

    Description of Event or Problem · 0

    THE CUSTOMER, A SYNCARDIA CERTIFIED HOSPITAL, REPORTED THAT THE FREEDOM DRIVER EXHIBITED A FAULT ALARM WHILE SUPPORTING THE PATIENT. THE CUSTOMER ALSO REPORTED THAT PATIENT CONDITIONS MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE. THE CUSTOMER ALSO REPORTED THAT THE PATIENT WAS SUBSEQUENTLY SWITCHED TO THE BACKUP FREEDOM DRIVER. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT.

    Additional Manufacturer Narrative · 1

    THIS ALLEGED FAILURE MODE POSES A LOW RISK TO THE PATIENT BECAUSE ALTHOUGH THE FREEDOM DRIVER EXHIBITED A FAULT ALARM, 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 CUSTOMER, A SYNCARDIA CERTIFIED HOSPITAL, REPORTED THAT THE FREEDOM DRIVER EXHIBITED A FAULT ALARM WHILE SUPPORTING THE PATIENT. THE CUSTOMER ALSO REPORTED THAT PATIENT CONDITIONS MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE. THE CUSTOMER ALSO REPORTED THAT THE PATIENT WAS SUBSEQUENTLY SWITCHED TO THE BACKUP FREEDOM DRIVER. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862260 SYNCARDIA FREEDOM DRIVER EXTERNAL PNEUMATIC DRIVER LOZ SYNCARDIA SYSTEMS, LLC 595000-001 00858000003121

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR