BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 3130183 · Received May 22, 2013

    Report

    Report Number
    2916596-2013-00602
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Date of Event
    April 25, 2013
    Report Date
    April 25, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT OF POWER CABLE DISCONNECT ALARMS AND CLOCK RESETS IN THE HISTORY WAS CONFIRMED WITH THE DATA CONTAINED IN THE LOG FILE. TWO CLOCK RESET EVENTS OCCURRED AFTER THE INTERMITTENT POWER CABLE DISCONNECT ALARM EVENTS. THE EVAL OF THE RETURNED SYSTEM CONTROLLER COULD NOT CONFIRM A RELATION TO THE DATA CONTAINED IN THE LOG FILE. DURING ANALYSIS, THE WHITE AND BLACK POWER LEADS WERE INDEPENDENTLY DISCONNECTED AND THE SYSTEM CONTINUED TO OPERATE SOLELY ON EITHER POWER LEAD WITHOUT ANY FUNCTIONAL ISSUE. FUNCTIONAL TESTING CONFIRMED ALL VISUAL AND AUDIO ALARMS FUNCTIONED AS INTENDED. THE DEVICE OPERATED ON A MOCK CIRCULATORY LOOP WITHOUT ANY NOTABLE EVENT. THE SEVERAL KINKS ON BOTH POWER LEADS DID NOT AFFECT THE SYSTEM CONTROLLER'S ABILITY TO OPERATE THE TEST PUMP. A REVIEW OF DEVICE HISTORY RECORDS FOR THIS DEVICE SHOWED NO DEVIATIONS FROM MFG OR QA SPECIFICATIONS. NO FURTHER INFO IS AVAILABLE. THE MFR IS CLOSING ITS FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. THE VAD COORDINATOR REPORTED THAT CLOCK RESETS ON THE LOG FILE HISTORY WERE RECORDED WITH MULTIPLE POWER CABLE DISCONNECTS. THE WHITE POWER CABLE WAS TORTUOUS WITH A SMALL TEAR. THE PATIENT EXCHANGED TO THE BACKUP SYSTEM CONTROLLER AND THE ISSUE WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227353 HEARTMATE II SYSTEM CONTROLLER DSQ: LVAD SYSTEM CONTROLLER DSQ THORATEC CORP. 103696 109019

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other