BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA FREEDOM AC POWER SUPPLY

    MDR report key: 5230563 · Received November 17, 2015

    Report

    Report Number
    3003761017-2015-00389
    Event Type
    Malfunction
    Date Received
    November 17, 2015
    Date of Event
    November 9, 2015
    Report Date
    November 9, 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

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE FREEDOM AC POWER SUPPLY IS A COMPONENT THAT ENABLES THE FREEDOM DRIVER TO BE PLUGGED INTO AN EXTERNAL POWER SOURCE. THE CUSTOMER REPORTED THAT THE FREEDOM AC POWER SUPPLY WAS NOT FUNCTIONING. THE CUSTOMER ALSO REPORTED THAT THE FREEDOM AC POWER SUPPLY WAS REPLACED. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. THE AC POWER SUPPLY WAS RETURNED TO SYNCARDIA FOR EVALUATION. VISUAL INSPECTION REVEALED THAT THE CABLE CONNECTOR COVER WAS NOT IN THE CORRECT ORIENTATION. THIS PREVENTED THE AC POWER SUPPLY FROM MAKING A PROPER CONNECTION TO PROVIDE POWER TO A FREEDOM POWER ADAPTOR OR BATTERY CHARGER. THE AC POWER SUPPLY CABLE WAS DISASSEMBLED, THE CONNECTOR KEY SLOT WAS ALIGNED WITH THE CONNECTOR COVER KEY TAB AND THE CORRECT MATING CONFIGURATION WAS OBTAINED. AFTER THE AC POWER SUPPLY CABLE WAS REASSEMBLED, THE AC POWER SUPPLY PASSED ALL REQUIRED FUNCTIONAL TESTING. THE ROOT CAUSE FOR THE OBSERVED ISSUE WAS THE INCORRECT ORIENTATION OF THE CONNECTOR COVER ON THE FREEDOM AC POWER SUPPLY, WHICH MAY RESULT FROM PROCESSES AT THE COMPONENT SUPPLIER OR SYNCARDIA. SYNCARDIA HAS IMPLEMENTED PROCESS CONTROLS TO IDENTIFY THIS ISSUE PRIOR TO RELEASE OF FREEDOM AC POWER SUPPLIES TO FINISHED GOODS AND TO ELIMINATE THE POTENTIAL FOR RECURRENCE. THE OCCURRENCE RATE FOR THIS ISSUE IS EXTREMELY LOW AND THERE IS NO IMPACT TO THE PATIENT. THE INCORRECT ORIENTATION OF THE CONNECTOR COVER IS IMMEDIATELY IDENTIFIABLE BY HOSPITAL PERSONNEL WHEN PREPARING THE FREEDOM DRIVER FOR PATIENT USE PER SECTION 7.5 OF F-900012, FREEDOM DRIVER SYSTEM OPERATOR MANUAL. THE FREEDOM DRIVER SYSTEM INCLUDES MULTIPLE POWER SOURCES AND POWER SUPPLY ACCESSORIES SUCH THAT OPERATION OF THE DRIVER IS NOT IMPACTED BY THIS ISSUE. 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 FREEDOM AC POWER SUPPLY IS A COMPONENT THAT ENABLES THE FREEDOM DRIVER TO BE PLUGGED INTO AN EXTERNAL POWER SOURCE. THE CUSTOMER REPORTED THAT THE FREEDOM AC POWER SUPPLY IS NOT FUNCTIONING. THE CUSTOMER ALSO REPORTED THAT THE PATIENT WAS SUBSEQUENTLY SWITCHED TO ANOTHER FREEDOM AC POWER SUPPLY. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. THIS ALLEGED FAILURE MODE POSES A LOW RISK TO THE PATIENT BECAUSE IT DID NOT PREVENT THE FREEDOM DRIVER FROM PERFORMING ITS LIFE-SUSTAINING FUNCTIONS. THE FREEDOM DRIVER CONTINUED TO FUNCTION AS INTENDED. THE FREEDOM DRIVER HAS A REDUNDANT POWER SOURCE OF ONBOARD BATTERIES. THE FREEDOM AC POWER SUPPLY WILL BE RETURNED TO SYNCARDIA FOR EVALUATION. THE RESULTS OF THE INVESTIGATION WILL BE PROVIDED IN A FOLLOW-UP MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759818 SYNCARDIA FREEDOM AC POWER SUPPLY AC POWER SUPPLY LOZ SYNCARDIA SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR