BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA FREEDOM DRIVER

    MDR report key: 6165954 · Received December 12, 2016

    Report

    Report Number
    3003761017-2016-00385
    Event Type
    Malfunction
    Date Received
    December 12, 2016
    Date of Event
    November 28, 2016
    Report Date
    November 28, 2016
    Manufacturer
    SYNCARDIA SYSTEMS, LLC
    Product Code
    LOZ
    UDI-DI
    00858000003121
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FREEDOM DRIVER WAS RETURNED TO SYNCARDIA FOR EVALUATION. THE DRIVER PASSED ALL PRESSURE TEST REQUIREMENTS, WHICH INCLUDED CARDIAC OUTPUT, RAP (RIGHT ATRIAL PRESSURE), AOP (AORTIC PRESSURE), PAP (PULMONARY ARTERIAL PRESSURE) AND LAP (LEFT ATRIAL PRESSURE) PERFORMANCE METRICS ASSOCIATED WITH NOMINAL NORMOTENSIVE AND HYPERTENSIVE SETTINGS. REVIEW OF THE ELECTRONIC DATA REVEALED A FAULT CODE OF "BOTTOM PRESSURE TOO HIGH" WHICH IS INDICATIVE OF A POTENTIALLY FAILING U22 PRESSURE SENSOR ON THE MAIN PCBA (PRINTED CIRCUIT BOARD ASSEMBLY) AND IS CONSISTENT WITH THE ALARM THAT THE CUSTOMER EXPERIENCED. FURTHER INVESTIGATION OF THE MAIN PCBA CONFIRMED THAT THE ROOT CAUSE FOR THE REPORTED FAULT ALARM WAS A DEGRADED PRESSURE SENSOR (U22) ON THE MAIN PCBA. 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 3603 FOLLOW-UP REPORT 1.

    Additional Manufacturer Narrative · 1

    THIS ALLEGED FAILURE MODE POSES A LOW RISK TO THE PATIENT BECAUSE ALTHOUGH THE FREEDOM DRIVER EXHIBITED A FAULT ALARM, IT 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.

    Description of Event or Problem · 1

    THE CUSTOMER, A SYNCARDIA CERTIFIED HOSPITAL, REPORTED THAT THE FREEDOM DRIVER EXHIBITED A FAULT ALARM WHILE SUPPORTING A PATIENT. THE CUSTOMER ALSO REPORTED THAT THE PATIENT WAS SWITCHED TO A BACK-UP FREEDOM DRIVER WITHOUT ANY ADVERSE PATIENT IMPACT.

    Description of Event or Problem · 1

    THE CUSTOMER, A SYNCARDIA CERTIFIED HOSPITAL, REPORTED THAT THE FREEDOM DRIVER EXHIBITED A FAULT ALARM WHILE SUPPORTING A PATIENT. THE CUSTOMER ALSO REPORTED THAT THE PATIENT WAS SWITCHED TO A BACK-UP FREEDOM DRIVER WITHOUT ANY ADVERSE PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819333 SYNCARDIA FREEDOM DRIVER EXTERNAL PNEUMATIC DRIVER LOZ SYNCARDIA SYSTEMS, LLC 00858000003121

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR