BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA FREEDOM DRIVER

    MDR report key: 4812379 · Received May 27, 2015

    Report

    Report Number
    3003761017-2015-00174
    Event Type
    Malfunction
    Date Received
    May 27, 2015
    Date of Event
    May 15, 2005
    Report Date
    May 18, 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) FOLLOW-UP REPORT 1.

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT 2: PLEASE NOTE THAT THIS IS A CORRECTED REPORT: PLEASE RETRACT INITIAL MDR AND FOLLOW-UP REPORT 1 MDR, THE REPORTED INCIDENT IS ON A PATIENT THAT IS IN AN INVESTIGATIONAL DEVICE EXEMPTION (IDE) STUDY AND THIS INCIDENT WILL BE REPORTED UNDER THE IDE STUDY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE FREEDOM DRIVER EXHIBITED INTERMITTENT FAULT ALARMS WHILE THE PT WAS SITTING UP. THE PT WAS SUBSEQUENTLY SWITCHED TO THE BACKUP FREEDOM DRIVER. THERE WAS NO REPORTED ADVERSE PT IMPACT. THIS ALLEGED FAILURE MODE POSES A LOW RISK TO THE PT BECAUSE ALTHOUGH THE FREEDOM DRIVER EXHIBITED INTERMITTENT FAULT ALARMS, 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 FREEDOM DRIVER EXHIBITED INTERMITTENT FAULT ALARMS WHILE THE PATIENT WAS SITTING UP. THE PATIENT WAS SUBSEQUENTLY SWITCHED TO THE BACKUP FREEDOM DRIVER. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. VISUAL INSPECTION OF THE DRIVER'S EXTERNAL COMPONENTS REVEALED A FRACTURE IN THE HOUSING ON THE POWER ADAPTOR SIDE. VISUAL INSPECTION OF THE DRIVER'S INTERNAL COMPONENTS REVEALED A FRACTURED BOSS WITH RAISED INSERT AT THE BOTTOM LEFT OF THE HOUSING. THE FRACTURES OBSERVED DURING INSPECTION ARE INDICATIONS OF ROUGH HANDLING BUT A LINK TO THE INTERMITTENT ALARM OCCURRENCES COULD NOT BE CONCLUSIVELY DETERMINED. REVIEW OF THE ALARM HISTORY ELECTRONIC DATA REVEALED THAT THE DRIVER DID NOT RECORD A PERMANENT FAULT ALARM WHILE SUPPORTING THE PATIENT. ONLY PERMANENT FAULT ALARMS ARE LATCHED IN THE ELECTRONIC RECORD. INTERMITTENT, RECOVERABLE, AND BATTERY ALARMS ARE NOT RECORDED. THE DRIVER, AS IN RECEIVED CONDITION, PASSED ALL PRE-BURN IN TEST REQUIREMENTS, WHICH INCLUDED NORMOTENSIVE AND HYPERTENSIVE SETTINGS, WITH NO ANOMALIES OR ALARMS. IN ADDITION, THE DRIVER WAS TESTED FOR AN ADDITIONAL 96 HOURS AND PERFORMED AS INTENDED WITH NO ISSUES. THE CUSTOMER EXPERIENCE WAS NOT DUPLICATED, AND THE ROOT CAUSE COULD NOT BE DETERMINED. THE DRIVER PERFORMED AS INTENDED, AND THERE WAS NO EVIDENCE OF A DEVICE MALFUNCTION. DESPITE THE CUSTOMER-REPORTED INTERMITTENT FAULT ALARMS, 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 HOUSINGS, AND PASSED ALL FUNCTIONAL AND PERFORMANCE TESTING PRIOR TO 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE FREEDOM DRIVER EXHIBITED INTERMITTENT FAULT ALARMS WHILE THE PATIENT WAS SITTING UP. THE PATIENT WAS SUBSEQUENTLY SWITCHED TO THE BACKUP FREEDOM DRIVER. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. VISUAL INSPECTION OF THE DRIVER'S EXTERNAL COMPONENTS REVEALED A FRACTURE IN THE HOUSING ON THE POWER ADAPTOR SIDE. VISUAL INSPECTION OF THE DRIVER'S INTERNAL COMPONENTS REVEALED A FRACTURED BOSS WITH RAISED INSERT AT THE BOTTOM LEFT OF THE HOUSING. THE FRACTURES OBSERVED DURING INSPECTION ARE INDICATIONS OF ROUGH HANDLING BUT A LINK TO THE INTERMITTENT ALARM OCCURRENCES COULD NOT BE CONCLUSIVELY DETERMINED. REVIEW OF THE ALARM HISTORY ELECTRONIC DATA REVEALED THAT THE DRIVER DID NOT RECORD A PERMANENT FAULT ALARM WHILE SUPPORTING THE PATIENT. ONLY PERMANENT FAULT ALARMS ARE LATCHED IN THE ELECTRONIC RECORD. INTERMITTENT, RECOVERABLE, AND BATTERY ALARMS ARE NOT RECORDED. THE DRIVER, AS IN RECEIVED CONDITION, PASSED ALL PRE-BURN IN TEST REQUIREMENTS, WHICH INCLUDED NORMOTENSIVE AND HYPERTENSIVE SETTINGS, WITH NO ANOMALIES OR ALARMS. IN ADDITION, THE DRIVER WAS TESTED FOR AN ADDITIONAL 96 HOURS AND PERFORMED AS INTENDED WITH NO ISSUES. THE CUSTOMER EXPERIENCE WAS NOT DUPLICATED, AND THE ROOT CAUSE COULD NOT BE DETERMINED. THE DRIVER PERFORMED AS INTENDED, AND THERE WAS NO EVIDENCE OF A DEVICE MALFUNCTION. DESPITE THE CUSTOMER-REPORTED INTERMITTENT FAULT ALARMS, 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 HOUSINGS, AND PASSED ALL FUNCTIONAL AND PERFORMANCE TESTING PRIOR TO 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
    343201 SYNCARDIA FREEDOM DRIVER EXTERNAL PNEUMATIC DRIVER LOZ SYNCARDIA SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR