BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA FREEDOM DRIVER

    MDR report key: 4898729 · Received July 1, 2015

    Report

    Report Number
    3003761017-2015-00209
    Event Type
    Malfunction
    Date Received
    July 1, 2015
    Date of Event
    May 7, 2015
    Report Date
    May 7, 2015
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE FREEDOM DRIVER DISPLAYED "HIGH TEMPERATURE" FAULT ALARM WHILE SUPPORTING A PATIENT. THE CUSTOMER ALSO REPORTED THAT THE PATIENT WAS SWITCHED TO THE BACKUP DRIVER WITHOUT ANY ADVERSE PATIENT IMPACT. FREEDOM DRIVER S/N (B)(4) WAS RETURNED TO SYNCARDIA FOR EVALUATION. VISUAL INSPECTION OF THE INTERIOR AND EXTERIOR OF THE DRIVER REVEALED NO ABNORMALITIES. THE DRIVER PASSED ALL TESTING REQUIREMENTS, WHICH INCLUDED NORMOTENSIVE AND HYPERTENSIVE SETTINGS, WITH NO ANOMALIES, ALARMS OR ANY UNUSUAL HEAT. THE DRIVER WAS TESTED FOR AN ADDITIONAL 48 HOURS AND PERFORMED AS INTENDED WITH NO ISSUES. THE CUSTOMER EXPERIENCE WAS NOT DUPLICATED AND THE ROOT CAUSE OF THE CUSTOMER REPORTED ALARM COULD NOT BE DETERMINED. THE ONBOARD BATTERIES USED BY THE CUSTOMER WERE NOT RETURNED AND THEREFORE COULD NOT BE INCLUDED IN THIS INVESTIGATION. A TEMPERATURE ALARM IS A RECOVERABLE ALARM AND CAN OCCUR IF THE INTERNAL TEMPERATURE OF THE FREEDOM DRIVER IS TOO HOT, OR THE TEMPERATURE OF THE ONBOARD BATTERIES BECOME TOO HOT OR TOO COLD. ADDITIONALLY, IF THE FREEDOM DRIVER'S COOLING AND AIR FILTER SYSTEMS ARE PARTIALLY OBSTRUCTED, THESE EVENTS CAN CONTRIBUTE TO AN OVERHEATING EVENT, WHICH CAN SUBSEQUENTLY TRIGGER A TEMPERATURE ALARM AS EXPERIENCED BY THE CUSTOMER. THE FREEDOM DRIVER PERFORMED AS INTENDED, AND THERE WAS NO EVIDENCE OF A DEVICE MALFUNCTION. THE DRIVER WAS SERVICED AND PASSED ALL FINAL PERFORMANCE TESTING. THE CUSTOMER-REPORTED TEMPERATURE ALARM POSED A LOW RISK TO THE PATIENT BECAUSE THE DRIVER CONTINUED TO PERFORM ITS LIFE-SUSTAINING FUNCTIONS. 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE FREEDOM DRIVER DISPLAYED "HIGH TEMPERATURE" FAULT ALARM WHILE SUPPORTING A PATIENT. THE CUSTOMER ALSO REPORTED THAT THE PATIENT WAS SWITCHED TO THE BACKUP DRIVER WITHOUT ANY ADVERSE PATIENT IMPACT. THIS ALLEGED FAILURE MODE POSES A LOW RISK TO THE PATIENT BECAUSE ALTHOUGH THE FREEDOM DRIVER DISPLAYED A "HIGH TEMPERATURE" FAULT ALARM, IT DID NOT PREVENT THE FREEDOM DRIVER FROM PERFORMING ITS LIFE-SUSTAINING FUNCTIONS. THE FREEDOM DRIVER WILL BE RETURNED TO SYNCARDIA FOR EVALUATION. THE RESULTS OF THE INVESTIGATION WILL BE PROVIDED IN SUPPLEMENTAL MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429355 SYNCARDIA FREEDOM DRIVER EXTERNAL PNEUMATIC DRIVER LOZ SYNCARDIA SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR