BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART

    MDR report key: 3180208 · Received June 4, 2013

    Report

    Report Number
    3003761017-2013-00064
    Event Type
    Malfunction
    Date Received
    June 4, 2013
    Date of Event
    May 22, 2013
    Report Date
    June 4, 2013
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CLINICIANS ARE TRAINED TO THREAD A WIRE TIE THROUGH THE THUMB RELEASE TAB OF QUICK CONNECTORS TO PREVENT INADVERTENT DISCONNECTION OF THE CANNULATE TO THE DRIVELINES. IT IS POSSIBLE THAT WHEN THE WIRE TIE WAS THREADED THROUGH THE CONNECTOR, IT DISLODGED THE SPRING, WHICH BECAME LODGED BENEATH THE THUMB RELEASE TAB. APPROPRIATE HOSPITAL PERSONNEL WILL BE RE-TRAINED TO AVOID SPRING DISPLACEMENT BY NOT FORCING THE WIRE TIES INTO THE QUICK CONNECTORS. THERE WAS NO PT IMPACT. THE PT IS STILL IMPLANTED WITH THE TAH-T AND WAS SUCCESSFULLY SWITCHED TO A PORTABLE FREEDOM DRIVER. THIS ALLEGED FAILURE MODE POSES A LOW RISK TO THE PT, BECAUSE IT DOES NOT PREVENT THE TAH-T SYSTEM FROM PERFORMING ITS LIFE-SUSTAINING FUNCTIONS. 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 ISSUE WILL CONTINUE TO BE MONITORED AND TRENDED AS PART OF THE CUSTOMER EXPERIENCE PROCESS. SYNCARDIA HAS COMPLETED ITS EVAL OF THIS COMPLAINT AND IS CLOSING THIS FILE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE SWITCHING THE PT FROM A SYNCARDIA COMPANION 2 DRIVER TO A PORTABLE SYNCARDIA FREEDOM DRIVER, SHE OBSERVED THAT THE SPRING INSIDE THE TAH-T QUICK CONNECTOR BETWEEN THE BODY OF THE CONNECTOR AND THE THUMB RELEASE TAB WAS TWISTED AND STUCK. THE CUSTOMER ALSO REPORTED THAT SHE DIDN'T KNOW IF THE SPRING WAS TWISTED WHEN THE WIRE TIE WAS THREADED THROUGH THE THUMB RELEASE TAB DURING IMPLANT SURGERY. THE QUICK CONNECTOR WAS REPLACED BY HOSPITAL STAFF. THERE WAS NO IMPACT ON THE PT. THE QUICK CONNECTOR WITH THE DISLODGED SPRING WILL NOT BE RETURNED TO SYNCARDIA FOR EVAL, BECAUSE THIS FAILURE MODE HAS BEEN PREVIOUSLY INVESTIGATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247793 SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART ARTIFICIAL HEART LOZ SYNCARDIA SYSTEMS, INC. TAH-T 084747

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR