BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 1935402 · Received November 17, 2010

    Report

    Report Number
    2916596-2010-00297
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Date of Event
    October 13, 2010
    Report Date
    October 21, 2010
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Removal / Correction Number
    29165969/2/10001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM CONTROLLER WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND THE REPORTED PERIODIC SINGLE TONE BEEP FROM THE SYSTEM CONTROLLER WAS CONFIRMED DURING ANALYSIS. THE LOG FILE WAS REVIEWED AND A NOTABLE NUMBER OF POWER CABLE DISCONNECT ALARMS WERE RECORDED OVER A SHORT PERIOD OF TIME, CONSISTENT WITH THE REPORTED EVENT. DURING THE EVALUATION, THE SYSTEM CONTROLLER DID NOT PASS THE TEST PROCEDURE DUE TO THE NUMBER OF LED'S DISPLAYED ON THE BATTERY GAUGE. DURING FURTHER INVESTIGATION, IT WAS FOUND THAT THE BROWN CONDUCTOR (BATTERY GAUGE LINE) OF THE BLACK POWER LEAD WAS KINKED, AND WHEN A SMALL AMOUNT OF PRESSURE WAS APPLIED IT BROKE. 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 A SINGLE TONE BEEP FROM THE SYSTEM CONTROLLER WAS OCCURRING EVERY FOUR TO FIVE MINUTES. IT WAS NOTED THAT THERE WAS FULL BATTERY POWER. THE PT WAS THEN CONNECTED TO THE POWER MODULE, BUT THERE WERE NO ALARMS, AND THERE WAS NO ALARM HISTORY NOTED THAT COINCIDED WITH THE EVENT. 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 CORPORATION 103696 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other