BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYS, CONTLLER, HMII, EUR, STERILE, EP

    MDR report key: 1935382 · Received November 11, 2010

    Report

    Report Number
    2916596-2010-00286
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    August 2, 2010
    Report Date
    October 15, 2010
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM CONTROLLER WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE REPORTED EVENT OF THE SYSTEM CONTROLLER ALARMING WAS CONFIRMED AND REPRODUCED DURING ANALYSIS. THE BLACK POWER LEAD WAS FOUND TO HAVE A SEVERED CONDUCTOR AT THE CONNECTOR END. MOVEMENT OF THE BLACK POWER LEAD AT THE CONNECTOR END RESULTED IN ALARMS AS WELL AS INTERRUPTION IN PUMP SUPPORT WHILE TETHERED TO THE POWER MODULE. A REVIEW OF DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE PT WAS AT HOME WHEN A CONSTANT AUDIO ALARM SOUNDED FROM THE SYSTEM CONTROLLER, ALONG WITH A RED HEART ALARM. AFTER VERIFYING ALL CONNECTIONS WERE SECURE, THE PT SWITCHED TO HIS BACK UP SYSTEM CONTROLLER AND THE ALARMS CEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYS, CONTLLER, HMII, EUR, STERILE, EP LVAD SYSTEM CONTROLLER DSQ THORATEC CORPORATION 103692 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention