BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA FREEDOM DRIVER

    MDR report key: 7013898 · Received November 9, 2017

    Report

    Report Number
    3003761017-2017-00208
    Event Type
    Malfunction
    Date Received
    November 9, 2017
    Date of Event
    October 25, 2017
    Report Date
    October 25, 2017
    Manufacturer
    SYNCARDIA SYSTEMS, LLC
    Product Code
    LOZ
    UDI-DI
    00858000003121
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FREEDOM DRIVER WAS RETURNED TO SYNCARDIA FOR EVALUATION. VISUAL INSPECTION OF THE DRIVER REVEALED METALLIC DEBRIS ON THE PISTON CYLINDER ASSEMBLY (PCA) AND MOTORS, SIGNS OF WEAR ON THE DOWEL PIN OF THE PCA SCOTCH YOKE, A SCRATCH MARK ON PCA ROD GUIDE PLATE, AND METALLIC DEBRIS ON THE MAIN PRINTED CIRCUIT BOARD ASSEMBLY (PCBA). THE DRIVER'S ALARM HISTORY WAS REVIEWED AND REVEALED ONE ALARM, A 29 FAULT CODE (LCD REGULATOR 1 TOO HIGH) WHICH IS LIKELY THE ALARM REPORTED BY THE CUSTOMER. WHILE THE CUSTOMER-REPORTED ALARM COULD NOT BE REPRODUCED DURING INVESTIGATION TESTING, IT IS LIKELY THAT THE METAL DEBRIS FROM THE PCA, CAUSED BY THE SCOTCH YOKE STRIKE PLATE/DOWEL PIN RUBBING AGAINST THE PCA BODY, CAUSED THE VOLTAGE FLUCTUATION ON THE MAIN PCBA, WHICH TRIGGERED THE 29 ALARM CODE TO BE RECORDED INTO THE ALARM HISTORY. THE DRIVER IN "AS RECEIVED" CONDITION PASSED ALL TEST REQUIREMENTS AND PRESSURE PERFORMANCE METRICS ASSOCIATED WITH NORMOTENSIVE AND HYPERTENSIVE SETTINGS. 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 FREEDOM DRIVER EXHIBITED A FAULT ALARM WHILE SUPPORTING A PATIENT. THE CUSTOMER ALSO REPORTED THAT THE PATIENT WAS SUBSEQUENTLY SWITCHED TO THE BACKUP FREEDOM DRIVER. THERE WAS NO REPORTED ADVERSE 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 WILL BE 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 FREEDOM DRIVER EXHIBITED A FAULT ALARM WHILE SUPPORTING A PATIENT. THE CUSTOMER ALSO REPORTED THAT THE PATIENT WAS SUBSEQUENTLY SWITCHED TO THE BACKUP FREEDOM DRIVER. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795096 SYNCARDIA FREEDOM DRIVER EXTERNAL PNEUMATIC DRIVER LOZ SYNCARDIA SYSTEMS, LLC 595000-001 00858000003121

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR