BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA FREEDOM DRIVER

    MDR report key: 12409206 · Received September 1, 2021

    Report

    Report Number
    3003761017-2021-00176
    Event Type
    Malfunction
    Date Received
    September 1, 2021
    Date of Event
    August 19, 2021
    Report Date
    February 2, 2022
    Manufacturer
    SYNCARDIA SYSTEMS, LLC
    Product Code
    LOZ
    UDI-DI
    00858000003121
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DRIVER'S ALARM HISTORY FILE WAS REVIEWED AND REVEALED FAULT CODES "22" AND "39" WHICH CAN OCCUR WHEN AN ONBOARD BATTERY IS REMOVED TOO QUICKLY, NOT GIVING ENOUGH TIME FOR THE SYSTEM TO RECOGNIZE THE FIRST ONBOARD BATTERY HAS BEEN INSERTED IN THE DRIVER, OR IF THE SECOND ONBOARD BATTERY IS NOT PROPERLY INSERTED AND PRODUCES AN INTERMITTENT COMMUNICATION. THESE ARE MOST LIKELY THE ALARMS EXPERIENCED BY THE CUSTOMER. DURING THE FUNCTIONAL TESTING, THE DRIVER DID NOT MEET PERFORMANCE SPECIFICATIONS DUE TO THE RIGHT-SIDE SPEAKER PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) VALUES BEING UNDER THE SPECIFIED DB REQUIREMENTS OF 75-90 DB; THIS WAS ATTRIBUTED A MALFUNCTION OF THE SPEAKER PCBA, WHICH IS UNRELATED TO THE CUSTOMER-REPORTED ISSUE. (SECTION H6 CODES 1198, 427, 120, 4307). IN AN ATTEMPT TO RECREATE THE CUSTOMER-REPORTED ALARM BATTERY EXCHANGE TESTING WAS PERFORMED USING EIGHT DIFFERENT FREEDOM ONBOARD BATTERIES. THE TESTING DEMONSTRATED THAT THE DRIVER FUNCTIONED AS INTENDED AND THE CUSTOMER-REPORTED ISSUE WAS NOT ABLE TO BE REPRODUCED. THE CONDITIONS THAT CAUSED THE DRIVER TO ANNUNCIATE A FAULT ALARM CANNOT BE CONCLUSIVELY DETERMINED. (SECTION H6 CODES 3189, 213, 67). F-900013-EN, REV 006, FREEDOM DRIVER SYSTEM OPERATOR MANUAL, SECTION 1.3.8, ONBOARD BATTERIES, INSTRUCTS THE USER TO WAIT FIVE SECONDS BETWEEN REPLACING THE FIRST BATTERY AND REMOVING THE SECOND ONE. THIS ENSURES THAT THE REPLACEMENT BATTERY HAS ACTIVATED AND IS SOURCING POWER TO THE FREEDOM DRIVER. OTHERWISE, A PERMANENT FAULT ALARM CAN BE TRIGGERED. THIS ISSUE WILL BE MONITORED AND TRENDED AS PART OF THE CUSTOMER EXPERIENCE 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. THE CUSTOMER, A SYNCARDIA CERTIFIED HOSPITAL, REPORTED THAT THE PATIENT'S BACKUP FREEDOM DRIVER ALARMED IMMEDIATELY THE MOMENT THE BATTERY WAS PUT IN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1303138 SYNCARDIA FREEDOM DRIVER EXTERNAL PNEUMATIC DRIVER LOZ SYNCARDIA SYSTEMS, LLC 595000-001 00858000003121

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female