BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA FREEDOM DRIVER

    MDR report key: 4703957 · Received April 15, 2015

    Report

    Report Number
    3003761017-2015-00128
    Event Type
    Malfunction
    Date Received
    April 15, 2015
    Date of Event
    April 7, 2015
    Report Date
    April 7, 2015
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT SUBSEQUENTLY SWITCHED TO THE BACKUP FREEDOM DRIVER AND FREEDOM AC POWER SUPPLY. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. THIS FAILURE MODE POSED A LOW RISK TO THE PATIENT BECAUSE IT DID NOT PREVENT THE FREEDOM DRIVER FROM PERFORMING ITS LIFE-SUSTAINING FUNCTIONS. DURING TESTING THE CUSTOMER-REPORTED BATTERY DISCHARGE ISSUE COULD NOT BE DUPLICATED. THE FREEDOM DRIVER AND AC POWER SUPPLY PERFORMED AS INTENDED, AND THERE WAS NO EVIDENCE OF A DEVICE MALFUNCTION. IN ADDITION, THE FREEDOM DRIVER HAS A REDUNDANT POWER SOURCE OF ONBOARD BATTERIES, AND PATIENTS ARE PROVIDED WITH MULTIPLE ONBOARD BATTERIES. 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.

    Additional Manufacturer Narrative · 1

    THE PATIENT SUBSEQUENTLY SWITCHED TO THE BACKUP FREEDOM DRIVER AND FREEDOM A/C POWER SUPPLY. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. THIS ALLEGED FAILURE MODE POSES A LOW RISK TO THE PATIENT BECAUSE ALTHOUGH THE FREEDOM ONBOARD BATTERIES WERE DISCHARGED WHILE THE PATIENT'S FREEDOM DRIVER WAS CONNECTED TO EXTERNAL WALL POWER BY THE A/C POWER SUPPLY, THE DRIVER CONTINUED TO PERFORM ITS LIFE-SUSTAINING FUNCTIONS. IN ADDITION, PATIENTS ARE PROVIDED WITH SEVERAL ONBOARD BATTERIES. THE FREEDOM DRIVER WILL BE RETURNED TO SYNCARDIA FOR EVALUATION. THE RESULTS OF THE INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTAL MDR.

    Description of Event or Problem · 1

    THE REPORTED ISSUE INVOLVES 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) AND FREEDOM A/C POWER SUPPLY S/N (B)(4) (MFR REPORT # 3003761017-2015-00129). THE CUSTOMER REPORTED THAT THE PATIENT'S FREEDOM ONBOARD BATTERIES DISCHARGED WHILE HIS FREEDOM DRIVER WAS CONNECTED TO EXTERNAL WALL POWER BY THE A/C POWER SUPPLY. THE CUSTOMER ALSO REPORTED THAT THE PATIENT ATTEMPTED TO RESOLVE THE ISSUE BY SWITCHING TO A DIFFERENT POWER ADAPTOR, WHICH CONNECTS THE A/C POWER SUPPLY TO THE DRIVER. HOWEVER, THE ISSUE DID NOT RESOLVE.

    Description of Event or Problem · 1

    THE REPORTED ISSUE INVOLVES 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 #3003761017-2015-00128) AND (2) FREEDOM AC POWER SUPPLY S/N (B)(4) (MFR REPORT #3003761017-2015-00129). THE CUSTOMER REPORTED THAT THE PATIENT'S FREEDOM ONBOARD BATTERIES DISCHARGED WHILE HIS FREEDOM DRIVER WAS CONNECTED TO EXTERNAL WALL POWER BY THE AC POWER SUPPLY. THE CUSTOMER ALSO REPORTED THAT THE PATIENT ATTEMPTED TO RESOLVE THE ISSUE BY SWITCHING TO A DIFFERENT POWER ADAPTOR, WHICH CONNECTS THE AC POWER SUPPLY TO THE DRIVER. HOWEVER, THE ISSUE DID NOT RESOLVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252695 SYNCARDIA FREEDOM DRIVER CIRCULATORY ASSIST DEVICE LOZ SYNCARDIA SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR