BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA FREEDOM DRIVER

    MDR report key: 13014578 · Received December 15, 2021

    Report

    Report Number
    3003761017-2021-00241
    Event Type
    Malfunction
    Date Received
    December 15, 2021
    Date of Event
    October 1, 2021
    Report Date
    September 15, 2022
    Manufacturer
    SYNCARDIA SYSTEMS, LLC
    Product Code
    LOZ
    UDI-DI
    00858000003121
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: SECTION B3 TO (B)(6) 2021. SECTION G3 TO 10/07/2021. THE DRIVER PASSED ALL STEPS OF THE FUNCTIONAL TESTING WHICH INCLUDED A TEST OF THE LOCKING MECHANISM FOR FREEDOM ONBOARD BATTERIES. ADDITIONAL TESTING WAS PERFORMED USING DUMMY BATTERIES IN AN ATTEMPT TO REPRODUCE THE CUSTOMER-REPORTED ISSUE. DURING THIS TESTING, IT WAS DEMONSTRATED THAT THE DUMMY BATTERY COULD BE REMOVED IF IT WAS "WIGGLED" WHILE PRESSING THE LOCK BUTTON. IT WAS ALSO OBSERVED THAT THE WIDTH OF THE DUMMY BATTERIES IS SLIGHTLY LESS THAN THE WIDTH OF THE FREEDOM ONBOARD BATTERY. THIS ALLOWS ENOUGH SPACE FOR THE DUMMY BATTERY TO BE "WIGGLED" ENOUGH TO BREAK FREE OF THE LOCKING MECHANISM. THIS TEST WAS REPERFORMED ON 5 INVENTORY DRIVERS WITH THEIR ISSUED DUMMY BATTERIES WITH THE SAME RESULTS. THE CUSTOMER-REPORTED ISSUE OF THE DUMMY BATTERY BEING REMOVED TOO EASILY WAS CONFIRMED DURING INVESTIGATIONAL TESTING. THE ROOT CAUSE COULD BE ATTRIBUTED TO THE SMALLER SIZE OF THE DUMMY BATTERY WHEN COMPARED TO THE FREEDOM ONBOARD BATTERY. NO EVIDENCE OF A DEVICE MALFUNCTION WAS FOUND DURING INVESTIGATION TESTING. THERE IS NO SPECIFICATION THAT DEFINES THE FORCE OR EFFORT REQUIRED TO REMOVE THE DUMMY BATTERY FROM THE DRIVER. F-900013-EN, FREEDOM DRIVER SYSTEM OPERATOR MANUAL - US, STATES THE FOLLOWING: "THE DUMMY BATTERY SHOULD ONLY BE REMOVED FROM THE BACKUP FREEDOM DRIVER AFTER INSERTING AN ONBOARD BATTERY WHEN SWITCHING THE PRIMARY FREEDOM DRIVER TO THE BACKUP FREEDOM DRIVER BECAUSE OF A FAULT ALARM THAT CANNOT BE RESOLVED." THIS ISSUE WILL BE TRACKED AND TRENDED AS A PART OF THE CUSTOMER COMPLAINT PROCESS. SYNCARDIA HAS COMPLETED ITS INVESTIGATION AND IS CLOSING THIS FILE. (B)(4) FOLLOW-UP REPORT 1.

    Additional Manufacturer Narrative · 0

    THE FREEDOM DRIVER WILL BE RETURNED TO SYNCARDIA FOR EVALUATION. THE RESULTS WILL BE PROVIDED IN A FOLLOW-UP MDR. (B)(4).

    Description of Event or Problem · 0

    THE FREEDOM DRIVER WAS NOT SUPPORTING A PATIENT AT THE TIME OF THE REPORTED EVENT. THE CUSTOMER, A SYNCARDIA AUTHORIZED DISTRIBUTOR, REPORTED THAT THE FREEDOM DRIVER DUMMY BATTERY REMOVES TOO EASILY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1912370 SYNCARDIA FREEDOM DRIVER EXTERNAL PNEUMATIC DRIVER LOZ SYNCARDIA SYSTEMS, LLC 595000-001 00858000003121

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown