BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCARDIA CIRCULATORY SUPPORT SYSTEM CONSOLE

    MDR report key: 6063816 · Received October 28, 2016

    Report

    Report Number
    3003761017-2016-00364
    Event Type
    Malfunction
    Date Received
    October 28, 2016
    Date of Event
    October 14, 2016
    Report Date
    October 14, 2016
    Manufacturer
    SYNCARDIA SYSTEMS, LLC
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CSS CONSOLE WAS RETURNED TO SYNCARDIA FOR EVALUATION. THE CUSTOMER-REPORTED UNSUCCESSFUL CALIBRATION WAS CONFIRMED. THE ROOT CAUSE WAS DETERMINED TO BE THAT THE PRINTED CIRCUIT ASSEMBLY (PCA) DRIFTED BEYOND THE SCOPE OF CALIBRATION THAT CAN BE PERFORMED BY THE HOSPITAL STAFF. 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. (B)(4) 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 CSS CONSOLE WAS NOT SUPPORTING A PATIENT. THE CSS CONSOLE WILL BE RETURNED TO SYNCARDIA FOR EVALUATION. THE RESULTS OF THE INVESTIGATION WILL BE PROVIDED IN A FOLLOW-UP MDR. (B)(4) INITIAL.

    Description of Event or Problem · 1

    THIS CSS CONSOLE WAS NOT SUPPORTING A PATIENT. THE CUSTOMER REPORTED THAT HE COULD NOT GET THE CSS CONSOLE TO CALIBRATE.

    Description of Event or Problem · 1

    THIS CSS CONSOLE WAS NOT SUPPORTING A PATIENT. THE CUSTOMER REPORTED THAT HE COULD NOT GET THE CSS CONSOLE TO CALIBRATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714552 SYNCARDIA CIRCULATORY SUPPORT SYSTEM CONSOLE EXTERNAL PNEUMATIC DRIVER LOZ SYNCARDIA SYSTEMS, LLC CSS CONSOLE 37

    Patients

    Seq Age Sex Outcome Treatment
    1