BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA FREEDOM DRIVER

    MDR report key: 5998419 · Received October 4, 2016

    Report

    Report Number
    3003761017-2016-00337
    Event Type
    Malfunction
    Date Received
    October 4, 2016
    Date of Event
    September 25, 2016
    Report Date
    September 27, 2016
    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 · 1

    THIS ALLEGED FAILURE MODE POSES A LOW RISK TO THE PATIENT BECAUSE ALTHOUGH THE FREEDOM DRIVER EXHIBITED FAULT ALARMS, IT CONTINUED TO PERFORM ITS LIFE-SUSTAINING FUNCTIONS. 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).

    Additional Manufacturer Narrative · 1

    THE FREEDOM DRIVER WAS RETURNED TO SYNCARDIA FOR EVALUATION. THE DRIVER IN "AS RECEIVED" CONDITION PASSED ALL FUNCTIONAL TEST REQUIREMENTS, WHICH INCLUDED TESTING AT NORMOTENSIVE AND HYPERTENSIVE SETTINGS, WITH NO ANOMALIES OR ALARMS. IN ADDITION, THE DRIVER WAS PLACED ON A 48 HOUR OBSERVATION RUN AND WAS CONFIRMED TO PERFORM AS INTENDED WITH NO ISSUES. THERE WAS NO EVIDENCE OF A DEVICE MALFUNCTION. THE RESULTS OF THE INVESTIGATION INDICATE THAT THE LIKELY CAUSE FOR THE CUSTOMER-REPORTED ALARMS WAS A KINKING OF THE DRIVELINES WHEN THE PATIENT BENT OVER. BY DESIGN, THE DRIVER WILL ALARM IF THE CARDIAC OUTPUT (CO) ON THE DRIVER FALLS BELOW 3.5 LPM. THE CUSTOMER REPORTED THAT CO DROPPED INTO THIS RANGE, SO AN ALARM WOULD BE EXPECTED. INVESTIGATION TESTING CONFIRMED THAT THE DRIVER ALARMED DURING DRIVELINE KINK TEST AND PERFORMED AS INTENDED. 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).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHEN THE PATIENT BENT OVER, THE FREEDOM DRIVER EXHIBITED A FAULT ALARM THAT RESOLVED. THE PATIENT BENT OVER A SECOND TIME AND THE FREEDOM DRIVER EXHIBITED A FAULT ALARM THAT DID NOT RESOLVE. THE CUSTOMER ALSO REPORTED THAT THE PATIENT WAS SUBSEQUENTLY SWITCHED TO A BACKUP FREEDOM DRIVER. THERE WAS NO REPORTED PATIENT IMPACT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHEN THE PATIENT BENT OVER, THE FREEDOM DRIVER EXHIBITED A FAULT ALARM THAT RESOLVED. THE PATIENT BENT OVER A SECOND TIME AND THE FREEDOM DRIVER EXHIBITED A FAULT ALARM THAT DID NOT RESOLVE. THE CUSTOMER ALSO REPORTED THAT THE PATIENT WAS SUBSEQUENTLY SWITCHED TO A BACKUP FREEDOM DRIVER. THERE WAS NO REPORTED PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649468 SYNCARDIA FREEDOM DRIVER EXTERNAL PNEUMATIC DRIVER LOZ SYNCARDIA SYSTEMS, LLC 00858000003121

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR