BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNCARDIA COMPANION 2 DRIVER

    MDR report key: 3423420 · Received August 30, 2013

    Report

    Report Number
    3003761017-2013-00101
    Event Type
    Other
    Date Received
    August 30, 2013
    Date of Event
    August 14, 2013
    Report Date
    August 29, 2013
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED ISSUE POSES A LOW RISK TO THE PATIENT BECAUSE IT WOULD NOT PREVENT THE COMPANION 2 DRIVER FROM PERFORMING ITS LIFE-SUSTAINING FUNCTIONS. 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT COMPANION 2 DRIVER S/N (B)(4) SUPPORTING A PATIENT DISPLAYED A "SYSTEM MALFUNCTION" ALARM. CARDIAC OUTPUT DURING THAT TIME WAS STABLE AT APPROXIMATELY 6.5 LITERS PER MINUTE. THE PATIENT WAS SWITCHED TO A BACKUP DRIVER WITHOUT IMPACT. THE CUSTOMER REPORTED THAT AFTER THE PATIENT WAS SWITCHED TO THE BACKUP DRIVER, COMPANION 2 DRIVER S/N 10067 PASSED A SYSTEM CHECK. THE CUSTOMER ALSO REPORTED THAT THE "SYSTEM MALFUNCTION" ALARM WAS LIKELY TRIGGERED BY SWITCHING THE PATIENT TOO QUICKLY AFTER TURNING THE DRIVER ON OR NOT CONNECTING THE DRIVER TO WALL AIR. THE CUSTOMER ALSO REPORTED THAT BECAUSE OF THE SEQUENCE OF EVENTS BEFORE THE ALARM AND BECAUSE IT PASSED THE SYSTEM CHECK, IT WAS DECIDED THAT THE DRIVER WAS SAFE FOR PATIENT USE, AND THE DRIVER WILL NOT BE RETURNED TO SYNCARDIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429894 SYNCARDIA COMPANION 2 DRIVER CIRCULATORY ASSIST DEVICE LOZ SYNCARDIA SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR