BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA CIRCULATORY SUPPORT SYSTEM CONSOLE

    MDR report key: 5836835 · Received August 1, 2016

    Report

    Report Number
    3003761017-2016-00275
    Event Type
    Malfunction
    Date Received
    August 1, 2016
    Date of Event
    July 13, 2016
    Report Date
    July 13, 2016
    Manufacturer
    SYNCARDIA SYSTEMS, LLC
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) INITIAL

    Additional Manufacturer Narrative · 1

    THE CSS CONSOLE WAS RETURNED TO SYNCARDIA FOR EVALUATION. THE ROOT CAUSE OF THE REPORTED ISSUE WAS THE MALFUNCTION OF A HIGH PRESSURE O-RING TO SECURELY SEAL AGAINST THE AIR TANK VALVE. THIS IS A COMPONENT THAT IS SERVICEABLE BY THE CUSTOMER WITH A TOOL KIT, REPLACEMENT O-RINGS, AND INSTRUCTIONS FOR REPLACEMENT PROVIDED WITH THE CSS CONSOLE. WHEN ANY CSS CONSOLE IS SHIPPED FROM SYNCARDIA, A TOOL KIT (P/N350041-001) IS ISSUED TO IT AND WILL TRAVEL WITH THE CSS CONSOLE WHENEVER THE CSS CONSOLE IS SHIPPED TO DIFFERENT LOCATIONS. WITHIN THAT TOOL KIT ARE REPLACEMENT O-RINGS THAT CAN BE USED IF NEEDED TO BE REPLACED IN THE FIELD. INSTRUCTIONS ON REPLACING THE O-RINGS ARE PROVIDED IN THE CIRCULATORY SUPPORT SYSTEM (CSS) AND WCOMDU USER'S MANUAL (P/N 950001-001) AT SECTION 5.4. 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. (B)(4) FOLLOW-UP REPORT 1.

    Description of Event or Problem · 1

    THIS CSS CONSOLE WAS NOT SUPPORTING A PATIENT. THE CUSTOMER REPORTED THAT THERE WAS A LOUD HISSING SOUND WHEN THE RESERVE AIR TANK WAS OPENED. THIS ALLEGED FAILURE MODE POSES A LOW RISK TO A PATIENT BECAUSE THE ISSUE WAS OBSERVED WHEN THE CSS CONSOLE WAS NOT SUPPORTING A PATIENT. IN ADDITION, IT WOULD NOT PREVENT THE CSS CONSOLE FROM PERFORMING ITS LIFE-SUSTAINING FUNCTIONS. THE CSS CONSOLE WILL BE RETURNED TO SYNCARDIA FOR EVALUATION. THE RESULTS OF THE INVESTIGATION WILL BE PROVIDED IN A FOLLOW-UP MDR.

    Description of Event or Problem · 1

    THIS CSS CONSOLE WAS NOT SUPPORTING A PATIENT. THE CUSTOMER REPORTED THAT THERE WAS A LOUD HISSING SOUND WHEN THE RESERVE AIR TANK WAS OPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490841 SYNCARDIA CIRCULATORY SUPPORT SYSTEM CONSOLE EXTERNAL PNEUMATIC DRIVER LOZ SYNCARDIA SYSTEMS, LLC CSS CONSOLE 11

    Patients

    Seq Age Sex Outcome Treatment
    1