BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART

    MDR report key: 2233053 · Received July 26, 2011

    Report

    Report Number
    3003761017-2011-00018
    Event Type
    Malfunction
    Date Received
    July 26, 2011
    Date of Event
    June 29, 2011
    Report Date
    July 25, 2011
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    LOZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO ROOT CAUSE OF THE DISLODGMENT OF THE SPRING IN THE CONNECTOR CAN BE CONFIRMED. CLINICIANS AND (B)(6) STUDY SUBJECTS ARE TRAINED TO THREAD A WIRE TIE THROUGH THE THUMB RELEASE TAB OF QUICK CONNECTORS TO PREVENT INADVERTENT DISCONNECTION OF THE CANNULAE TO THE DRIVELINES. IT IS POSSIBLE THAT WHEN THE WIRE TIE WAS THREADED THROUGH THE CONNECTOR, IT DISLODGED THE SPRING, WHICH BECAME DISLODGED BENEATH THE THUMB RELEASE TAB. WHILE IT CAN BE DIFFICULT TO DEPRESS THE PUSH BUTTON TO RELEASE THE QUICK CONNECTORS WHEN THE SPRING IS NOT SEATED CORRECTLY, IT IS POSSIBLE TO DISCONNECT THEM BY USING ADDITIONAL FORCE. THIS FAILURE MODE POSES A LOW RISK TO THE PT, BECAUSE IT DOES NOT PREVENT THE TAH-T SYSTEM FROM PERFORMING ITS LIFE-SUSTAINING FUNCTIONS. THERE WAS NO IMPACT ON THE SUBJECT, AND REPLACEMENT OF THE QUICK CONNECTOR BY HOSPITAL PERSONNEL RESOLVED THE ISSUE. THIS IS THE SECOND REPORTED INSTANCE OF DISLODGMENT OF THE SPRING IN THE THUMB RELEASE TAB OF A QUICK CONNECTOR. THIS FAILURE MODE WILL CONTINUE TO BE TRACKED AND TRENDED THROUGH THE SYNCARDIA CUSTOMER EXPERIENCE PROCESS. SYNCARDIA HAS COMPLETED ITS EVALUATION OF THIS COMPLAINT AND IS CLOSING THIS FILE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT WHILE A (B)(6) STUDY SUBJECT, IMPLANTED WITH THE SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T), WAS BEING SWITCH FROM HER PRIMARY FREEDOM DRIVER TO HER BACKUP FREEDOM DRIVER, THE CLINICIAN FOUND IT DIFFICULT TO DEPRESS AND RELEASE THE TAH-T QUICK CONNECTOR BECAUSE THE THUMB DEPRESSION SPRING WAS INCORRECTLY SEATED IN ITS HOUSING. THE CLINICAL REPLACED THE QUICK CONNECTOR, RESOLVING THE ISSUE. THERE WAS NO ADVERSE IMPACT ON THE SUBJECT. THE QUICK CONNECTOR WAS RETURNED TO SYNCARDIA FOR EVALUATION. INSPECTION CONFIRMED THAT ITS THUMB DEPRESSION SPRING WAS INCORRECTLY SEATED IN THE HOUSING. THE SPRING WAS WEDGED BETWEEN THE BODY OF THE CONNECTOR AND THE THUMB RELEASE TAB.

    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 070328

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR