BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART

    MDR report key: 2062732 · Received April 12, 2011

    Report

    Report Number
    3003761017-2011-00010
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    March 19, 2011
    Report Date
    April 11, 2011
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    LOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON INSPECTION, A SMALL LINEAR TEAR IN THE RIGHT VENTRICLE CANNULA WAS NOTED ABOVE THE CONNECTION SITE AND ADJACENT TO THE WIRE REINFORCED PORTION OF THE CANNULA. THIS TEAR ALLOWED AIR TO ESCAPE, RESULTING IN DECREASED FILL VOLUMES IN THE 30S. THE TEAR IN THE CANNULA WAS REPAIRED BY THE HOSPITAL BY SEALING IT WITH SUPER GLUE, ELIMINATING THE AIR LEAK. THE CANNULA WAS FURTHER REINFORCED WITH A SEGMENT OF 1/2" TUBING THAT WAS GLUED OVER THE AREA OF THE REPAIRED TEAR AND SECURED WITH TIE BANDS. AFTER THE AIR LEAK WAS REPAIRED, THE FILL VOLUMES RETURNED INTO THE UPPER 50S WITH A CARDIAC OUTPUT OF SEVEN LITERS/MINUTE. THE CUSTOMER REPORTED THAT THERE WAS NO ADVERSE IMPACT ON THE PT. SYNCARDIA HAS REQUESTED THAT THE TAH-T AND CANNULA BE RETURNED TO SYNCARDIA FOR EVAL AFTER THE PT HAS BEEN TRANSPLANTED. THE RESULTS OF THE EVAL WILL BE PROVIDED IN A SUPPLEMENTAL MDR.

    Description of Event or Problem · 1

    PT (B)(6) WAS IMPLANTED WITH THE SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) ON (B)(6) 2010. HE WAS TRANSFERRED FROM THE CIRCULATORY SUPPORT SYSTEM (CSS) CONSOLE TO THE INVESTIGATIONAL FREEDOM DRIVER SYSTEM ON (B)(6) 2011. THE PT REPORTED THAT SHORTLY AFTER THE DRIVER TRANSFER, HE BEGAN TO NOTICE INTERMITTENT "HISSING" OF AIR THAT OCCURRED WHEN HE CHANGED HIS BODY POSITION. ON (B)(6), THE PT BEGAN TO EXPERIENCE LOW FILL VOLUMES, FOLLOWED BY INTERMITTENT FREEDOM DRIVER FAULT ALARMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART ARTIFICIAL HEART LOZ SYNCARDIA SYSTEMS, INC. TAH-T 069303

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention