BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA FREEDOM DRIVER

    MDR report key: 7038732 · Received November 16, 2017

    Report

    Report Number
    3003761017-2017-00213
    Event Type
    Malfunction
    Date Received
    November 16, 2017
    Date of Event
    October 30, 2017
    Report Date
    October 30, 2017
    Manufacturer
    SYNCARDIA SYSTEMS, LLC
    Product Code
    LOZ
    UDI-DI
    00858000003121
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FREEDOM DRIVER WAS RETURNED TO SYNCARDIA FOR EVALUATION. VISUAL INSPECTION OF THE DRIVER REVEALED THAT THE SECONDARY MOTOR CAM FOLLOWER WAS OUT OF THE BOTTOM DEAD CENTER (BDC) POSITION. THE DRIVER'S ALARM HISTORY WAS REVIEWED AND REVEALED TWO NEW ALARMS: 2D (SECONDARY MOTOR VOLTAGE TOO HIGH) AND 2F (SYSTEM CURRENT TOO HIGH). THE FIRST ALARM WAS LIKELY RECORDED DURING THE SERVICE PROCESS PRIOR TO SHIPMENT TO THE CUSTOMER. THE SECOND ALARM WAS LIKELY RECORDED DURING PATIENT SUPPORT AS A RESULT OF SECONDARY MOTOR ENGAGEMENT, WHICH CORRELATES TO THE FINDINGS DURING THE VISUAL INSPECTION. DURING INVESTIGATION TESTING, BOTH THE PRIMARY AND SECONDARY MOTOR CIRCUITS OF THE DRIVER WERE TESTED AND FUNCTIONED AS INTENDED. ADDITIONALLY, THE ONBOARD BATTERIES USED DURING THE CUSTOMER-REPORTED ISSUE WERE TESTED AND FUNCTIONED AS INTENDED WITH NO ANOMALIES. THE ROOT CAUSE OF THE SECONDARY MOTOR ENGAGING (WHICH CAUSED THE DRIVER ALARM) COULD NOT BE DETERMINED, BUT MAY HAVE BEEN CAUSED BY IMPACT SHOCK AS A RESULT OF ROUGH HANDLING OR A NEAR DROP (JOLT) DURING USE AS A BACKUP DRIVER. THE DEVICE HISTORY RECORD INDICATED THAT THE DRIVER WAS USED AS A BACKUP DRIVER FOR 49 DAYS PRIOR PATIENT SUPPORT. THE FREEDOM DRIVER PERFORMED AS INTENDED WITH NO EVIDENCE OF A DEVICE MALFUNCTION. 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 · 0

    THE CUSTOMER, A SYNCARDIA CERTIFIED HOSPITAL, REPORTED THAT THE PATIENT SWITCHED ONTO HIS BACKUP FREEDOM DRIVER AND AFTER A FEW MINUTES THE DRIVER EXHIBITED A FAULT ALARM. THE CUSTOMER ALSO REPORTED THAT THE PATIENT WAS TRANSPORTED TO THE HOSPITAL AND SUBSEQUENTLY SWITCHED TO A COMPANION 2 DRIVER. THE CUSTOMER ALSO REPORTED THAT THE PATIENT WAS HYPERTENSIVE AT FIRST AND THEN QUIETED DOWN. THERE WAS NO REPORTED PERMANENT PATIENT IMPACT.

    Additional Manufacturer Narrative · 1

    THIS ALLEGED FAILURE MODE POSES A LOW RISK TO THE PATIENT BECAUSE ALTHOUGH THE FREEDOM DRIVER EXHIBITED A FAULT ALARM, IT CONTINUED TO PERFORM ITS LIFE-SUSTAINING FUNCTIONS. THE FREEDOM DRIVER HAS BEEN RETURNED TO SYNCARDIA FOR EVALUATION. THE RESULTS OF THE INVESTIGATION WILL BE PROVIDED IN A FOLLOW-UP MDR. (B)(4) INITIAL.

    Description of Event or Problem · 1

    THE CUSTOMER, A SYNCARDIA CERTIFIED HOSPITAL, REPORTED THAT THE PATIENT SWITCHED ONTO HIS BACKUP FREEDOM DRIVER AND AFTER A FEW MINUTES THE DRIVER EXHIBITED A FAULT ALARM. THE CUSTOMER ALSO REPORTED THAT THE PATIENT WAS TRANSPORTED TO THE HOSPITAL AND SUBSEQUENTLY SWITCHED TO A COMPANION 2 DRIVER. THE CUSTOMER ALSO REPORTED THAT THE PATIENT WAS HYPERTENSIVE AT FIRST AND THEN QUIETED DOWN. THERE WAS NO REPORTED PERMANENT PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    815784 SYNCARDIA FREEDOM DRIVER EXTERNAL PNEUMATIC DRIVER LOZ SYNCARDIA SYSTEMS, LLC 595000-001 00858000003121

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR