BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA FREEDOM AC POWER SUPPLY

    MDR report key: 5564282 · Received April 8, 2016

    Report

    Report Number
    3003761017-2016-00134
    Event Type
    Malfunction
    Date Received
    April 8, 2016
    Date of Event
    March 23, 2016
    Report Date
    March 23, 2016
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) FOLLOW-UP.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THIS FREEDOM HOSPITAL AC POWER SUPPLY WAS NOT IN PATIENT USE. THE FREEDOM HOSPITAL AC POWER SUPPLY IS A COMPONENT THAT ENABLES THE FREEDOM DRIVER TO BE PLUGGED INTO AN EXTERNAL POWER SOURCE. THE CUSTOMER REPORTED THAT THE GREEN CONNECTOR WILL NOT FIT THE FREEDOM DRIVER OR THE FREEDOM BATTERY CHARGER. THE HOSPITAL 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 HOSPITAL AC POWER SUPPLY FROM MAKING A PROPER CONNECTION TO PROVIDE POWER TO A FREEDOM POWER ADAPTOR OR BATTERY CHARGER. THE HOSPITAL 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 HOSPITAL AC POWER SUPPLY CABLE WAS REASSEMBLED, THE HOSPITAL 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 HOSPITAL 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 HOSPITAL AC POWER SUPPLIES TO FINISHED GOODS AND TO ELIMINATE THE POTENTIAL FOR RECURRENCE. THE OCCURRENCE RATE FOR THIS ISSUE IS REMOTE 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

    THIS FREEDOM AC POWER SUPPLY WAS NOT IN PATIENT USE. 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 GREEN CONNECTOR WILL NOT FIT THE FREEDOM DRIVER OR THE FREEDOM BATTERY CHARGER. THIS ALLEGED FAILURE MODE POSES A LOW RISK TO A PATIENT BECAUSE THIS ISSUE WAS OBSERVED WHEN THE FREEDOM AC POWER SUPPLY WAS NOT IN USE BY A PATIENT. IN ADDITION, THE REPORTED ISSUE WOULD NOT PREVENT THE FREEDOM DRIVER FROM PERFORMING ITS LIFE-SUSTAINING FUNCTIONS. 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
    218922 SYNCARDIA FREEDOM AC POWER SUPPLY AC POWER SUPPLY LOZ SYNCARDIA SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1