BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 3123633 · Received May 15, 2013

    Report

    Report Number
    2916596-2013-00587
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 16, 2013
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM CONTROLLER WAS RETURNED TO THE MFR FOR EVAL AND IS CURRENTLY BEING ANALYZED. THE MFR IS ATTEMPTING TO ACQUIRE THE PT CABLE FOR ANALYSIS. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORT ((B)(4)) WAS RECEIVED FROM THE INTERMACS REGISTRY WHICH STATED THAT THE PUMP WAS "OFF" AND THAT THIS WAS DISCOVERED WHEN THE VAD WAS INTERROGATED. WAVEFORMS WERE SENT IN FOR REVIEW AND AN X-RAY OF THE DRIVELINE WAS ORDERED. IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PT WAS EXPERIENCING RED HEART ALARMS DURING POWER SOURCE CHANGES. UPON REVIEW OF THE PT HISTORY LOG, THE VAD COORDINATOR NOTED LOW SPEED AND PUMP STOP EVENTS. PRELIMINARY TROUBLESHOOTING DETECTED A POSSIBLE PT CABLE ISSUE WHERE PROPER VOLTAGE WAS NOT BEING SUPPLIED TO THE SYSTEM CONTROLLER. THE PT'S SYSTEM CONTROLLER AND PT CABLE WERE EXCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214950 HEARTMATE II SYSTEM CONTROLLER DSQ: LVAD SYSTEM CCONTROLLER DSQ THORATEC CORPORATION 103696 10775

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other