BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA COMPANION 2 DRIVER

    MDR report key: 6151496 · Received December 7, 2016

    Report

    Report Number
    3003761017-2016-00384
    Event Type
    Malfunction
    Date Received
    December 7, 2016
    Date of Event
    November 28, 2016
    Report Date
    November 28, 2016
    Manufacturer
    SYNCARDIA SYSTEMS, LLC
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANION 2 DRIVER WAS RETURNED TO SYNCARDIA FOR EVALUATION. REVIEW OF THE PATIENT FILE REVEALED MULTIPLE SYSTEM CHECK FAILURES, WHICH ALIGNS WITH THE STATEMENTS MADE BY THE CUSTOMER. DURING INVESTIGATION TESTING, THE DRIVER FUNCTIONED AS INTENDED AND THERE WAS NO EVIDENCE OF A MALFUNCTION. THE CUSTOMER-REPORTED SYSTEM CHECK FAILURES WERE REPRODUCED BY OBSTRUCTING THE DRIVELINE PORT WITH ORANGE SHIPPING CAPS. BASED ON PREVIOUS EXPERIENCE, THIS USE ERROR IS THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT. THIS ISSUE WILL CONTINUE TO BE MONITORED AND TRENDED AS PART OF THE CUSTOMER EXPERIENCE PROCESS. SYNCARDIA HAS COMPLETED ITS EVALUATION OF THIS COMPLAINT AND IS CLOSING THIS FILE. CE 3602 FOLLOW-UP REPORT 1.

    Additional Manufacturer Narrative · 1

    THIS ALLEGED FAILURE MODE POSES A LOW RISK TO A PATIENT BECAUSE THE ISSUE WAS OBSERVED WHEN THE COMPANION 2 DRIVER WAS NOT SUPPORTING A PATIENT. THE COMPANION 2 DRIVER HAS BEEN RETURNED TO SYNCARDIA FOR EVALUATION. THE RESULTS OF THE EVALUATION WILL BE PROVIDED IN A FOLLOW-UP MDR. (B)(4).

    Description of Event or Problem · 1

    THE COMPANION 2 DRIVER WAS NOT SUPPORTING A PATIENT. THE CUSTOMER, A SYNCARDIA CERTIFIED HOSPITAL, REPORTED THAT THE COMPANION 2 DRIVER DID NOT PASS THE SYSTEM CHECKOUT.

    Description of Event or Problem · 1

    THE COMPANION 2 DRIVER WAS NOT SUPPORTING A PATIENT. THE CUSTOMER, A SYNCARDIA CERTIFIED HOSPITAL, REPORTED THAT THE COMPANION 2 DRIVER DID NOT PASS THE SYSTEM CHECKOUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801371 SYNCARDIA COMPANION 2 DRIVER EXTERNAL PNEUMATIC DRIVER LOZ SYNCARDIA SYSTEMS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1