BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART

    MDR report key: 2765347 · Received September 25, 2012

    Report

    Report Number
    3003761017-2012-00065
    Event Type
    Other
    Date Received
    September 25, 2012
    Date of Event
    September 11, 2012
    Report Date
    September 21, 2012
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    LOZ
    PMA / PMN Number
    P010011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNCARDIA INITIATED A CAPA (CORRECTIVE OR PREVENTIVE ACTION) TO ADDRESS THE CANNULA TEAR ISSUE. THE CAPA WILL DOCUMENT THE INVESTIGATION INCLUDING, BUT NOT LIMITED TO, POTENTIAL ROOT CAUSE AND CORRECTIVE ACTIONS ASSOCIATED WITH ALL CANNULA TEAR EVENTS. FROM 2004 TO (B)(4) 2012, THERE HAVE BEEN A TOTAL OF (B)(4) TAH-T IMPLANTS WORLDWIDE AND A TOTAL OF 18 TAH-T PATIENTS WHO EXPERIENCED A CANNULA BREACH, FOR A RATE OF ABOUT (B)(4). NONE OF THE PATIENTS EXPERIENCED ANY INJURIES AS A RESULT OF THE CANNULA TEARS. THEREFORE, THE RISK ASSOCIATED WITH THIS ISSUE IS LOW FOR OCCURRENCE AND LOW OR SEVERITY. SYNCARDIA REQUESTED THAT THE SECTION OF CANNULA THAT WAS REMOVED BE RETURNED TO SYNCARDIA FOR EVALUATION. THE RESULTS OF THE INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTAL MDR.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH THE SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) ON (B)(6) 2011. THE PATIENT WAS SUBSEQUENTLY SWITCHED FROM A CSS CONSOLE TO A FREEDOM PORTABLE DRIVER AND WAS DISCHARGED TO HOME. THE CUSTOMER REPORTED THAT ON (B)(6) 2012, 435 DAYS AFTER IMPLANT, THE PATIENT NOTED AN INTERMITTENT HISSING NOISE FROM HIS RIGHT TAH-T CANNULA. THE PATIENT TAPED THE CANNULA AND RETURNED TO THE HOSPITAL, WHERE A CANNULA TEAR ABOVE THE QUICK CONNECTOR WAS OBSERVED. THE DOCTOR CUT OFF THE CANNULA WHERE THE TEAR WAS LOCATED AND REPLACED THE QUICK CONNECTOR. THERE WAS NO ADVERSE IMPACT ON THE PATIENT, AND THE PATIENT WAS DISCHARGED TO HOME.

    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 072479

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention