BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA FREEDOM DRIVER

    MDR report key: 4484386 · Received January 29, 2015

    Report

    Report Number
    3003761017-2015-00032
    Event Type
    Malfunction
    Date Received
    January 29, 2015
    Date of Event
    January 14, 2015
    Report Date
    January 14, 2015
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PT'S FREEDOM DRIVER EXHIBITED A FAULT ALARM WHILE SWITCHING ONBOARD BATTERIES. THE CUSTOMER ALSO REPORTED THAT DURING THE ONBOARD BATTERY EXCHANGE, THE FREEDOM DRIVER WAS NOT CONNECTED TO THE FREEDOM A/C POWER SUPPLY. THE PT SUBSEQUENTLY CONNECTED THE FREEDOM A/C POWER SUPPLY TO THE FREEDOM DRIVER, BUT THE FAULT ALARM DID NOT RESOLVE. THE PT WAS HOSPITALIZED BECAUSE OF OTHER MEDICAL ISSUES AND SWITCHED TO A BACKUP FREEDOM DRIVER, THEN TO A COMPANION 2 DRIVER AND REMAINED IN THE HOSP UNTIL SUCCESSFULLY TRANSPLANTED. THERE WAS NO REPORTED ADVERSE PT IMPACT. THIS ALLEGED FAILURE MODE POSES A LOW RISK TO THE PT, BECAUSE, ALTHOUGH THE FREEDOM DRIVER EXHIBITED FAULT ALARMS WHILE SWITCHING ONBOARD BATTERIES, THE FREEDOM DRIVER CONTINUED TO PERFORM ITS LIFE-SUSTAINING FUNCTIONS. THE FREEDOM DRIVER WILL BE RETURNED TO SYNCARDIA FOR EVAL. THE RESULTS OF THE INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTAL MDR.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PATIENT'S FREEDOM DRIVER EXHIBITED A FAULT ALARM WHILE SWITCHING ONBOARD BATTERIES. THE CUSTOMER ALSO REPORTED THAT DURING THE ONBOARD BATTERY EXCHANGE, THE FREEDOM DRIVER WAS NOT CONNECTED TO THE FREEDOM A/C POWER SUPPLY. THE PATIENT SUBSEQUENTLY CONNECTED THE FREEDOM A/C POWER SUPPLY TO THE FREEDOM DRIVER, BUT THE FAULT ALARM DID NOT RESOLVE. THE PATIENT WAS HOSPITALIZED BECAUSE OF OTHER MEDICAL ISSUES AND SWITCHED TO A BACKUP FREEDOM DRIVER, THEN TO A COMPANION 2 DRIVER AND REMAINED IN THE HOSPITAL UNTIL SUCCESSFULLY TRANSPLANTED. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. THE FREEDOM DRIVER WAS RETURNED TO SYNCARDIA FOR EVALUATION. VISUAL INSPECTION OF THE EXTERNAL COMPONENTS OF THE DRIVER REVEALED NO ABNORMALITIES. THE ELECTRONIC DATA EXTRACTION REVEALED A "LEFT DRIVE PRESSURE TOO LOW FOR LONG ENOUGH TO BE PERMANENT TIME-OUT" FAULT, WHICH LIKELY OCCURRED DURING DRIVER EXCHANGE. THE U22 PRESSURE SENSOR ON THE MAIN PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) WAS NOT SUSPECTED TO BE DAMAGED OR MALFUNCTIONING BECAUSE OF ITS DAYS OF USE, AND THE DRIVER PERFORMED AS INTENDED DURING INVESTIGATION TESTING WITH NO ANOMALIES OR ALARMS. ONLY PERMANENT FAULT ALARMS ARE RECORDED IN THE DRIVER'S ALARM HISTORY. INTERMITTENT, RECOVERABLE AND BATTERY ALARMS ARE NOT RECORDED IN THE ELECTRONIC DATA. THE FREEDOM DRIVER IN AS RECEIVED CONDITION PASSED ALL TEST REQUIREMENTS, WHICH INCLUDED NORMOTENSIVE AND HYPERTENSIVE SETTINGS, WITH NO ANOMALIES OR ALARMS. THE CUSTOMER-REPORTED FAULT ALARM WAS NOT FUNCTIONALLY DUPLICATED DURING INCOMING INVESTIGATION TESTING. ADDITIONAL TESTING WAS PERFORMED TO CONFIRM THE DRIVER'S ABILITY TO DISCHARGE AND RECHARGE THE BATTERIES. THE DRIVER'S ELECTRONICS FUNCTIONED AS INTENDED. THE DRIVER PERFORMED AS INTENDED, AND THERE WAS NO EVIDENCE OF A DEVICE MALFUNCTION. DESPITE THE CUSTOMER-REPORTED FAULT ALARM, RISK TO THE PATIENT WAS LOW BECAUSE THE DRIVER CONTINUED TO PERFORM ITS LIFE-SUSTAINING-FUNCTIONS. THE FREEDOM DRIVER WAS SERVICED AND PASSED ALL FUNCTIONAL AND PERFORMANCE TESTING BEFORE BEING PLACED INTO FINISHED GOODS. 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
    69800 SYNCARDIA FREEDOM DRIVER EXTERNAL PNEUMATIC DRIVER LOZ SYNCARDIA SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR