BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA CIRCULATORY SUPPORT SYSTEM CONSOLE

    MDR report key: 1970512 · Received January 19, 2011

    Report

    Report Number
    3003761017-2011-00003
    Event Type
    Malfunction
    Date Received
    January 19, 2011
    Date of Event
    January 3, 2011
    Report Date
    January 18, 2011
    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

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A CSS CONSOLE THAT WAS SUPPORTING A PT EXHIBITED A "HIGH RIGHT DRIVELINE PRESSURE" ALARM. THE DRIVELINE PRESSURE ON THE CSS CONSOLE WAS SET AT 60, AND THE PT'S CARDIAC OUTPUT WAS NOT AFFECTED. THE PT WAS SWITCHED TO A BACKUP CSS CONSOLE. THERE WAS NO PT IMPACT. THIS ALLEGED FAILURE MODE POSES A LOW RISK TO THE PT, BECAUSE IT DOES NOT NEGATE THE ABILITY OF THE CSS CONSOLE TO PERFORM ITS LIFE-SUSTAINING FUNCTIONS. THE CSS CONSOLE COULD NOT BE RE-CALIBRATED AT THE HOSPITAL AND HAS BEEN RETURNED TO SYNCARDIA FOR EVAL. THE RESULTS OF THE EVAL WILL BE PROVIDED IN A SUPPLEMENTAL MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCARDIA CIRCULATORY SUPPORT SYSTEM CONSOLE CIRCULATORY ASSIST DEVICE LOZ SYNCARDIA SYSTEMS, INC. CSS CONSOLE 25

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR