BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA CIRCULATORY SUPPORT SYSTEM CONSOLE

    MDR report key: 1970511 · Received January 19, 2011

    Report

    Report Number
    3003761017-2011-00006
    Event Type
    Malfunction
    Date Received
    January 19, 2011
    Date of Event
    January 2, 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
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A SYNCARDIA CLINICAL SUPPORT REP REPORTED THAT DURING AN IMPLANT PROCEDURE OF THE SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T), THE INPUT AIR PRESSURE READING ON THE CSS CONSOLE WAS 30 PSI, ALTHOUGH THE WALL AIR PRESSURE WAS 52 PSI. THE CSS CONSOLE CONTINUED TO PROVIDE NORMAL PNEUMATIC PRESSURE TO THE TAH-T THROUGHOUT THE PROCEDURE. AFTER THE PT WAS TRANSFERRED TO THE ICU, AN ALTERNATIVE AIR HOSE WAS USED, AND THE INPUT AIR PRESSURE READING ON THE CSS CONSOLE WAS 52 PSI. THIS ALLEGED FAILURE MODE POSES A LOW RISK TO THE PT, BECAUSE THE REPORTED ISSUE DID NOT PREVENT THE CSS CONSOLE FROM PERFORMING ITS LIFE-SUSTAINING FUNCTIONS. THE CSS CONSOLE CONTINUED TO PROVIDE NORMAL PNEUMATIC PRESSURE TO THE TAH-T. THE CSS CONSOLE AIR HOSE WILL BE RETURNED TO SYNCARDIA FOR EVAL, AND THE RESULTS 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 16

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR