BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA FREEDOM DRIVER

    MDR report key: 11999911 · Received June 15, 2021

    Report

    Report Number
    3003761017-2021-00110
    Event Type
    Malfunction
    Date Received
    June 15, 2021
    Date of Event
    May 31, 2021
    Report Date
    June 30, 2022
    Manufacturer
    SYNCARDIA SYSTEMS, LLC
    Product Code
    LOZ
    UDI-DI
    00858000003121
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FREEDOM DRIVER'S ALARM HISTORY WAS REVIEWED AND REVEALED A 0X49 FAULT CODE WHICH IS RECORDED WHEN THE CARDIAC OUTPUT IS TOO LOW FOR LONG ENOUGH TO BE PERMANENT TIME-OUT. THIS CAN OCCUR WHEN THE PATIENT IS EXPERIENCING A HYPERTENSIVE OR HYPERVOLEMIC CONDITION. PER THE HOSPITAL'S MECHANICAL CIRCULATORY SUPPORT SPECIALIST, THE PATIENT WAS FLUID OVERLOADED. DURING INVESTIGATION TESTING, THE FREEDOM DRIVER WAS CONNECTED TO A PATIENT SIMULATOR TANK WHICH WAS SET TO THE PARAMETERS THAT MIMIC A PERSON'S FLUID OVERLOAD CONDITION. THE FREEDOM DRIVER ALARMED AS DESIGNED WHEN THE CARDIAC OUTPUT AND FILL VOLUME DROPPED BELOW 3.5 LPM. THE ALARM HISTORY WAS REVIEWED AND A NEW 0X49 CODE WAS PRESENT. THE ROOT CAUSE OF THE CUSTOMER-REPORTED FAULT ALARM WAS DETERMINED TO BE PATIENT CONDITIONS OUTSIDE THE USER REQUIREMENTS OF THE FREEDOM DRIVER. F-900012, SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEAT (TAH-T) WITH THE FREEDOM DRIVER SYSTEM OPERATOR MANUAL SECTION 2 INDICATIONS FOR USE STATES THAT THE FREEDOM DRIVER SYSTEM, USED WITH THE 50CC TAH-T OR THE 70CC TAH-T, IS INTENDED FOR IN-HOSPITAL AND OUT-OF HOSPITAL USE. THE TAH-T SYSTEM WITH THE SYNCARDIA FREEDOM DRIVER IS INDICATED FOR USE AS A BRIDGE TO TRANSPLANTATION IN CARDIAC TRANSPLANT CANDIDATES WHO ARE IMPLANTED WITH THE TAH-T AND ARE CLINICALLY STABLE. THIS ISSUE WILL BE MONITORED AND TRENDED AS 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 · 1

    THE FREEDOM DRIVER WILL BE RETURNED TO SYNCARDIA FOR EVALUATION. THE RESULTS WILL BE PROVIDED IN A FOLLOW-UP MDR. CE 5560 INITIAL.

    Description of Event or Problem · 1

    THE CUSTOMER, A SYNCARDIA CERTIFIED HOSPITAL, REPORTED THAT THE FREEDOM DRIVER EXHIBITED A FAULT ALARM WHILE SUPPORTING THE PATIENT. THE PATIENT HAD MISSED HIS LAST TWO SESSIONS FOR DIALYSIS AND THE CUSTOMER WAS CERTAIN THAT THE PATIENT WAS FLUID OVERLOADED. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. THE CUSTOMER ALSO REPORTED THAT THE PATIENT WAS SUBSEQUENTLY SWITCHED TO A BACKUP DRIVER AND THEY HAD BEEN TAKING FLUID OFF BY INCREASING PATIENT'S MEDICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    896537 SYNCARDIA FREEDOM DRIVER EXTERNAL PNEUMATIC DRIVER LOZ SYNCARDIA SYSTEMS, LLC 595000-001 00858000003121

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male