BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA FREEDOM DRIVER

    MDR report key: 5242660 · Received November 23, 2015

    Report

    Report Number
    3003761017-2015-00395
    Event Type
    Malfunction
    Date Received
    November 23, 2015
    Date of Event
    November 15, 2015
    Report Date
    November 15, 2015
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4) FOLLOW-UP REPORT 1

    Description of Event or Problem · 1

    THE REPORTED ISSUES INVOLVE THE FOLLOWING SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM COMPONENTS AND ARE REPORTED UNDER TWO SEPARATE MEDICAL DEVICE REPORTS: (1) PRIMARY FREEDOM DRIVER S/N (B)(4) (MFR REPORT # 3003761017-2015-00395) AND (2) FREEDOM DRIVER S/N (B)(4) (MFR REPORT # 3003761017-2015-00396). THE CUSTOMER REPORTED THAT THE FREEDOM DRIVER S/N (B)(4) EXHIBITED A BEAT RATE OF 122 BEATS PER MINUTE (BPM) THOUGH THE BEAT RATE WAS SET AT 125 BPM. ADDITIONALLY, THE FILL VOLUME (FV) EXHIBITED ON THE DRIVER WAS AT 49 MILLILITERS (ML). THE CUSTOMER ALSO REPORTED THAT THE PATIENT WAS TAKEN TO THE HOSPITAL WITH REPORTS OF FEELING A HEAD RUSH. THE CUSTOMER ALSO REPORTED THAT THE PATIENT WAS SUBSEQUENTLY SWITCHED TO THE BACKUP FREEDOM DRIVER S/N (B)(4) AT THE HOSPITAL, WHERE THE DRIVER EXHIBITED A FAULT ALARM. THE CUSTOMER ALSO REPORTED THAT THE PATIENT WAS SUBSEQUENTLY SWITCHED TO ANOTHER FREEDOM DRIVER AND THE PATIENT FELT FINE AFTER HE WAS SWITCHED. THE FREEDOM DRIVER WILL BE RETURNED TO SYNCARDIA FOR EVALUATION. THE RESULTS OF THE INVESTIGATION WILL BE PROVIDED IN A FOLLOW-UP MDR.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE FREEDOM DRIVER EXHIBITED A FAULT ALARM WHILE SUPPORTING A PATIENT AT HOME. THE REPORTED ISSUES INVOLVE THE FOLLOWING SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM COMPONENTS AND ARE REPORTED UNDER TWO SEPARATE MEDICAL DEVICE REPORTS: PRIMARY FREEDOM DRIVER S/N (B)(4) (MFR REPORT # 3003761017-2015-00395) AND FREEDOM DRIVER S/N (B)(4) (MFR REPORT # 3003761017-2015-00396). THE CUSTOMER REPORTED THAT THE FREEDOM DRIVER S/N (B)(4) EXHIBITED A BEAT RATE OF 122 BEATS PER MINUTE (BPM) THOUGH THE BEAT RATE WAS SET AT 125 BPM. ADDITIONALLY, THE FILL VOLUME (FV) EXHIBITED ON THE DRIVER WAS AT 49 MILLILITERS (ML). THE CUSTOMER ALSO REPORTED THAT THE PATIENT WAS TAKEN TO THE HOSPITAL WITH REPORTS OF FEELING A HEAD RUSH. THE CUSTOMER ALSO REPORTED THAT THE PATIENT WAS SUBSEQUENTLY SWITCHED TO THE BACKUP FREEDOM DRIVER S/N 4587 AT THE HOSPITAL, WHERE THE DRIVER EXHIBITED A FAULT ALARM. THE CUSTOMER ALSO REPORTED THAT THE PATIENT WAS SUBSEQUENTLY SWITCHED TO ANOTHER FREEDOM DRIVER AND THE PATIENT FELT FINE AFTER HE WAS SWITCHED. THE FREEDOM DRIVER S/N (B)(4) WAS RETURNED TO SYNCARDIA FOR EVALUATION. VISUAL INSPECTION OF THE DRIVER'S EXTERNAL COMPONENTS REVEALED NO ABNORMALITIES. REVIEW OF THE ELECTRONIC ALARM HISTORY DATA REVEALED ONE ALARM THAT CAN BE PRODUCED DURING MANUFACTURING/SERVICE PROCESS FUNCTIONAL TESTING. NO ALARMS WERE REPORTED BY THE CUSTOMER. THE DRIVER IN "AS RECEIVED" CONDITION PASSED ALL TEST REQUIREMENTS, WHICH INCLUDED NORMOTENSIVE AND HYPERTENSIVE SETTINGS, WITH NO ANOMALIES OR ALARMS. IN ADDITION, THE DRIVER WAS TESTED FOR AN ADDITIONAL 48 HOURS AND PERFORMED AS INTENDED WITH NO ISSUES. THERE WAS NO EVIDENCE OF A DEVICE MALFUNCTION. THE DRIVER PERFORMED AS INTENDED, AND THERE WAS NO EVIDENCE OF A MALFUNCTION DURING INVESTIGATION TESTING. DESPITE THE CUSTOMER-REPORTED EXPERIENCE, RISK TO THE PATIENT WAS LOW BECAUSE THE DRIVER CONTINUED TO PERFORM ITS LIFE-SUSTAINING FUNCTIONS. THE DRIVER WAS SERVICED, WHICH INCLUDED THE REPLACEMENT OF THE PISTON CYLINDER ASSEMBLY (PCA), AS A PRECAUTIONARY MEASURE BECAUSE THE OUTPUT PRESSURE WAS NEAR THE MINIMUM ACCEPTABLE OUTPUT OF 4.9 LITERS PER MINUTE (LPM) AND WAS NOTATED ON THE QUALITY CONTROL INSPECTION REPORT (QCIR), BEFORE BEING PLACED INTO FINISHED GOODS. THE RESULTS OF THE INVESTIGATION FOR FREEDOM DRIVER S/N (B)(4) WILL BE PROVIDED IN A SEPARATE FOLLOW-UP MDR. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775058 SYNCARDIA FREEDOM DRIVER EXTERNAL PNEUMATIC DRIVER LOZ SYNCARDIA SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR