BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 2193284 · Received July 13, 2011

    Report

    Report Number
    2916596-2011-00293
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 14, 2011
    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 DEVICE WAS RETURNED TO THE MFR FOR EVAL. THE SYSTEM CONTROLLER WAS CONNECTED TO THE EQUIPMENT IN THE MFR'S LAB WITH NO ALARMS ACTIVE. THE BLACK AND WHITE POWER LEADS WERE MANIPULATED AND WHILE MOVING THE WHITE POWER LEAD AT THE CONNECTOR END, THE SYSTEM REPORTED A "LOW BATTERY" ALARM FOLLOWED BY A "POWER CABLE DISCONNECTED" ALARM. THE SYSTEM CONTROLLER WAS REMOVED FROM THE TEST EQUIPMENT. THE OUTER INSULATION AND THE STRAIN RELIEF OF THE WHITE POWER LEAD AT THE CONNECTOR END WAS REMOVED REVEALING A BROKEN INNER CONDUCTOR. THIS SITUATION IS BEING ADDRESSED THROUGH THE MFR'S CORRECTIVE/PREVENTIVE ACTION SYSTEM AND AN URGENT MEDICAL DEVICE CORRECTION NOTICE (29165969/2/10001-C) WAS SENT TO CUSTOMERS. NO FURTHER INFO IS AVAILABLE. THE MFR 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 TRANSPLANT COORDINATOR REPORTED THAT THE VAD COORDINATOR RECEIVED A PHONE CALL FROM THE PT NOTING THAT HE WAS HAVING ONGOING INTERMITTENT ALARMS FROM HIS SYSTEM CONTROLLER. THE ALARMS WERE ASSOCIATED WITH THE FLASHING OF THE BATTERY LIGHTS. HE WAS ATTEMPTING TO TEST THE BATTERIES ON THE SYSTEM CONTROLLER, AND THEY TESTED FULL EVEN THOUGH THEY WERE COMPLETELY DEPLETED. THE PT STATED THAT OVERALL HE WAS FEELING WELL. IT WAS REPORTED THAT THE LVAD PARAMETERS WERE NORMAL WITH SPEED AT 10,200 RPMS. THE PT HAS BEEN COMPLETING NORMAL ACTIVITY AND HAS NOTED NO CHANGE IN HIS LVAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II SYSTEM CONTROLLER LVAD SYSTEM CONTROLLER DSQ THORATEC CORP. 103696 90899

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other