BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T)

    MDR report key: 10705484 · Received October 20, 2020

    Report

    Report Number
    3003761017-2020-00218
    Event Type
    Malfunction
    Date Received
    October 20, 2020
    Date of Event
    October 8, 2020
    Report Date
    July 12, 2022
    Manufacturer
    SYNCARDIA SYSTEMS, LLC
    Product Code
    LOZ
    UDI-DI
    00858000003008
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION OF THE RETURNED CANNULA PIECE CONFIRMED THE REPORTED ISSUE OF DISCOLORATION. THE INVESTIGATION COULD NOT DEFINITIVELY DETERMINE THE ROOT CAUSE OF THE CUSTOMER-REPORTED DISCOLORATION, BUT IT IS CONSISTENT WITH PREVIOUSLY REPORTED CANNULA DISCOLORATION. IT IS MOST LIKELY THAT THE DARKENING OF THE CANNULAE RESULTED FROM EXPOSURE TO ENVIRONMENTAL FACTORS IN THE PATIENT'S SURROUNDINGS. THE FREEDOM DRIVER SYSTEM OPERATOR MANUAL (F-900014) AND THE FREEDOM DRIVER SYSTEM GUIDEBOOK FOR PATIENTS AND CAREGIVERS (F-900015) INSTRUCT PATIENTS TO EXAMINE THEIR CANNULAE REGULARLY AND TO NOT USE CLEANERS ON THE DRIVELINES, CANNULAE, DRIVERS OR DRIVER ACCESSORIES. USERS ARE TO USE EXTREME CARE WHEN CLEANING THE FREEDOM DRIVER AND DRIVELINES, AND TO WIPE THE DRIVELINES GENTLY WITH A SOFT, CLEAN CLOTH LIGHTLY DAMPENED ONLY WITH WATER. THIS ISSUE WILL BE MONITORED AND TRENDED AS PART OF THE CUSTOMER COMPLAINT PROCESS. SYNCARDIA HAS COMPLETED ITS INVESTIGATION AND IS CLOSING THIS FILE. (B)(4) FOLLOW-UP REPORT 1 (2 OF 2).

    Additional Manufacturer Narrative · 1

    A PIECE OF THE PATIENT'S DISCOLORED CANNULA WILL BE SENT TO SYNCARDIA FOR EVALUATION. THE RESULTS WILL BE PROVIDED IN A FOLLOW-UP MDR. (B)(4) INITIAL.

    Description of Event or Problem · 1

    THE CUSTOMER, A SYNCARDIA CERTIFIED HOSPITAL, REPORTED THAT THE TAH-T CANNULAE WERE DISCOLORED. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1169216 SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) BIVENTRICULAR REPLACEMENT DEVICE LOZ SYNCARDIA SYSTEMS, LLC 500101-001 106901 00858000003008

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Male