BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA FREEDOM DRIVER

    MDR report key: 6815430 · Received August 23, 2017

    Report

    Report Number
    3003761017-2017-00147
    Event Type
    Malfunction
    Date Received
    August 23, 2017
    Date of Event
    August 13, 2017
    Report Date
    August 13, 2017
    Manufacturer
    SYNCARDIA SYSTEMS, LLC
    Product Code
    LOZ
    UDI-DI
    00858000003121
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ALLEGED FAILURE MODE POSES A LOW RISK TO A PATIENT BECAUSE THE ISSUE WAS OBSERVED WHEN THE FREEDOM DRIVER WAS NOT SUPPORTING A PATIENT. THE FREEDOM DRIVER HAS BEEN RETURNED TO SYNCARDIA FOR EVALUATION. THE RESULTS OF THE INVESTIGATION WILL BE PROVIDED IN A FOLLOW-UP MDR.

    Additional Manufacturer Narrative · 1

    THE FREEDOM DRIVER WAS RETURNED TO SYNCARDIA FOR EVALUATION. THE CUSTOMER-REPORTED EXPERIENCE OF THE DRIVER RUNNING WHILE THE ONBOARD BATTERIES WERE NOT FULLY INSERTED WAS REPRODUCED DURING INVESTIGATION TESTING. THE ELECTRICAL CONTACTS ARE AT THE BOTTOM OF THE BATTERY AND WHEN INSERTED INTO THE BATTERY WELL IT IS POSSIBLE FOR THE ELECTRICAL CONTACTS TO MAKE A CONNECTION BEFORE THE MECHANICAL LATCH IS ENGAGED. WHEN AN ONBOARD BATTERY IS NOT PROPERLY INSERTED, THE SAFETY BATTERY LATCH DOES NOT ENGAGE AND IS NOT ABLE TO LOCK THE BATTERY IN PLACE. THE DRIVER PASSED ALL FUNCTIONAL TEST REQUIREMENTS WHICH ALSO INCLUDED VERIFICATION OF THE BATTERY LOCKING MECHANISM; THERE WAS NO EVIDENCE OF A DEVICE MALFUNCTION. THE FREEDOM DRIVER SYSTEM OPERATOR MANUAL (F-900013, SECTION 6.5.2 AND 6.5.3) EXPLAINS THAT USERS SHOULD PUSH DOWN ON ONBOARD BATTERIES TO CONFIRM THAT THEY ARE LOCKED INTO PLACE IN THE DRIVER. THE MANUAL ALSO EXPLAINS HOW THE LOCKING MECHANISM OF THE FREEDOM DRIVER WORKS, AS FOLLOWS: INSERTING THE ONBOARD BATTERIES. THE ONBOARD BATTERIES ARE DESIGNED TO BE INSERTED CORRECTLY INTO THE DRIVER IN ONLY ONE DIRECTION. PUSH DOWN ON THE ONBOARD BATTERY UNTIL THE BATTERY IS LOCKED IN PLACE. CONFIRM THAT THE ONBOARD BATTERY IS LOCKED IN PLACE BY TRYING TO REMOVE IT WITHOUT PRESSING THE BATTERY RELEASE BUTTON. THE FREEDOM DRIVER HAS A MECHANISM THAT LOCKS ONE ONBOARD BATTERY INTO THE DRIVER AT ALL TIMES. THIS MECHANISM PREVENTS THE USER FROM ACCIDENTALLY REMOVING BOTH ONBOARD BATTERIES AT THE SAME TIME. WHEN ONE ONBOARD BATTERY IS REMOVED, THE INTERNAL MECHANISM WILL LOCK THE OTHER ONBOARD BATTERY IN PLACE, MAKING IT IMPOSSIBLE FOR TWO ONBOARD BATTERIES (THAT HAVE BEEN FULLY INSERTED PROPERLY) TO BE REMOVED AT THE SAME TIME. 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 · 1

    THE FREEDOM DRIVER WAS NOT SUPPORTING A PATIENT. THE CUSTOMER, A SYNCARDIA AUTHORIZED DISTRIBUTOR, REPORTED THAT THE FREEDOM DRIVER BATTERY WELL LATCH DID NOT LOCK IN PLACE A FREEDOM ONBOARD BATTERY. THE ONBOARD BATTERY COULD BE EASILY PULLED OUT OF THE WELL WITHOUT DEPRESSING THE RELEASE BUTTON.

    Description of Event or Problem · 1

    THE FREEDOM DRIVER WAS NOT SUPPORTING A PATIENT. THE CUSTOMER, A SYNCARDIA AUTHORIZED DISTRIBUTOR, REPORTED THAT THE FREEDOM DRIVER BATTERY WELL LATCH DID NOT LOCK IN PLACE A FREEDOM ONBOARD BATTERY. THE ONBOARD BATTERY COULD BE EASILY PULLED OUT OF THE WELL WITHOUT DEPRESSING THE RELEASE BUTTON. THE CUSTOMER ALSO REPORTED THAT THE FREEDOM DRIVER STARTED EVEN THOUGH THE ONBOARD BATTERY WAS NOT LATCHED INTO PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593656 SYNCARDIA FREEDOM DRIVER EXTERNAL PNEUMATIC DRIVER LOZ SYNCARDIA SYSTEMS, LLC 595000-001 00858000003121

    Patients

    Seq Age Sex Outcome Treatment
    1