BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 1931980 · Received November 30, 2010

    Report

    Report Number
    2916596-2010-00316
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Date of Event
    October 1, 2010
    Report Date
    November 1, 2010
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Removal / Correction Number
    29165969/2/10001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM CONTROLLER WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND THE REPORTED ALARMS WERE CONFIRMED DURING ANALYSIS. THE POWER CABLE DISCONNECT ALARM BECAME ACTIVE WHEN THE WHITE POWER LEAD WAS MANEUVERED. WHEN THE SYSTEM CONTROLLER WAS RUN BY JUST THE WHITE POWER LEAD, A YELLOW BATTERY ALARM BECAME ACTIVE AND PROGRESSED TO A RED BATTERY ALARM. DURING FURTHER INVESTIGATION, IT WAS FOUND THAT THE BROWN CONDUCTOR (BATTERY GAUGE LINE) OF THE BLACK POWER LEAD WAS BROKEN. THIS SITUATION IS BEING ADDRESSED THROUGH THE MANUFACTURER'S CORRECTIVE/ PREVENTATIVE ACTION SYSTEM AND AN URGENT MEDICAL DEVICE CORRECTION NOTICE (29165969/2/10001-C) WAS SENT TO CUSTOMERS. 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). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PT EXPERIENCED FREQUENT POWER CABLE DISCONNECT ALARMS AND OCCASIONAL LOW VOLTAGE ALARMS; SOME OF THE ALARMS OCCURRED IN THE MIDDLE OF THE NIGHT WHEN THE PT WAS SLEEPING. THE RANDOM ALARMS OCCURRED BOTH WHILE ON TETHERED OPERATION AND ON BATTERY. THE SYSTEM CONTROLLER WAS EXCHANGED AND THE ISSUE WAS RESOLVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR