BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA FREEDOM DRIVER

    MDR report key: 9883792 · Received March 26, 2020

    Report

    Report Number
    3003761017-2020-00094
    Event Type
    Malfunction
    Date Received
    March 26, 2020
    Date of Event
    March 12, 2020
    Report Date
    August 25, 2022
    Manufacturer
    SYNCARDIA SYSTEMS, LLC
    Product Code
    LOZ
    UDI-DI
    00858000003121
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION DID NOT REVEAL ANY DAMAGE CAUSED BY THE REPORTED DROP OF THE FREEDOM DRIVER. F-900015-DE, FREEDOM DRIVER SYSTEM GUIDEBOOK FOR PATIENTS AND CAREGIVERS OUS - GERMAN, LISTS SEVERAL CAUTIONS THAT IF THE FREEDOM DRIVER IS DROPPED, EXPOSED TO LIQUIDS/DEBRIS, SUBJECTED TO ROUGH HANDLING, IT MAY SUSTAIN DAMAGE THAT WILL NOT ALLOW IT TO PROVIDE LIFE-SUSTAINING FUNCTIONS AS DESIGNED. IF THE PRIMARY FREEDOM DRIVER IS DROPPED, EXPOSED TO LIQUIDS/DEBRIS OR IS SUBJECTED TO ROUGH HANDLING, OR IF THE FAULT ALARM CANNOT BE RESOLVED WITHIN IN THREE TO FOUR MINUTES, THE PATIENT MUST SWITCH TO THE BACKUP FREEDOM DRIVER. DURING INITIAL TESTING, THE DRIVER DID NOT MAINTAIN THE PROPER NORMOTENSIVE PRESSURE VALUES FOR LEFT ARTERIAL PRESSURE (LAP). ADDITIONAL TESTING WAS PERFORMED IN AN ATTEMPT TO REPRODUCE THE REPORTED UNSTABLE FILL VOLUMES. THE DRIVER WAS PLACED ON AN OBSERVATION RUN FOR APPROXIMATELY 5 DAYS. DURING THIS TIME, THE DRIVER DID NOT EXHIBIT ANY ALARMS AND FILL VOLUMES AND CARDIAC OUTPUT VALUES REMAINED STABLE. THE ROOT CAUSE OF THE CUSTOMER-REPORTED UNSTABLE FLOWS COULD NOT BE CONCLUSIVELY DETERMINED. (H6-3189, 4756, 213, 67) THE ROOT CAUSE THE FREEDOM DRIVER DID NOT MAINTAIN THE PROPER NORMOTENSIVE LAP VALUES DURING TESTING WAS DETERMINED TO BE A MALFUNCTION OF THE PISTON CYLINDER ASSEMBLY. THIS MALFUNCTION IS UNRELATED TO THE CUSTOMER-REPORTED ISSUE. (H6-3005, 4756, 180, 4307) SYNCARDIA HAS A CORRECTIVE AND PREVENTATIVE ACTION (CAPA) FOR THE ISSUE OF FREEDOM DRIVER ELEVATED LEFT ARTERIAL PRESSURE (LAP) DURING TESTING. SYNCARDIA HAS COMPLETED ITS INVESTIGATION AND IS CLOSING THIS FILE. CE 5239 (B)(4). FOLLOW-UP REPORT 1.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER, A SYNCARDIA CERTIFIED HOSPITAL, REPORTED THAT THE FREEDOM DRIVER EXHIBITED UNSTABLE FILL VOLUMES WHILE SUPPORTING A PATIENT. WHEN THE PATIENT WAS CHECKED AT THE CLINIC, HE REPORTED THAT HE HAD DROPPED THE FREEDOM DRIVER A FEW DAYS EARLIER AND THAT IS WHEN THE UNSTABLE FILL VOLUMES HAD BEGUN. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. THE CUSTOMER ALSO REPORTED THAT THE PATIENT WAS SUBSEQUENTLY SWITCHED TO A BACKUP FREEDOM DRIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346810 SYNCARDIA FREEDOM DRIVER EXTERNAL PNEUMATIC DRIVER LOZ SYNCARDIA SYSTEMS, LLC 595000-001 00858000003121

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male