BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 3082469 · Received April 25, 2013

    Report

    Report Number
    2916596-2013-00505
    Event Type
    Injury
    Date Received
    April 25, 2013
    Date of Event
    April 6, 2012
    Report Date
    March 28, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM CONTROLLER SERIAL NUMBER (B)(4) WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE EVALUATION WAS ABLE TO CONFIRM UNUSUAL INTERRUPTIONS IN THE PUMP FUNCTION BASED ON THE REVIEW OF THE RETURNED SYSTEM CONTROLLER LOG FILE. THE LOG FILE CONTAINED APPROXIMATELY 15 DAYS OF DATA. EVENTS WERE RECORDED APPROXIMATELY 6 DAYS PRIOR TO THE REMOVAL OF THE SYSTEM CONTROLLER WHERE THE PUMP STOPPED TWICE, ACCOMPANIED BY THE EXPECTED LOW SPEED HAZARD ALARM. THE SYSTEM CONTROLLER WAS EVALUATED WHILE CONNECTED TO TEST LAB EQUIPMENT AND WAS DETERMINED TO BE FUNCTIONING AS EXPECTED DURING ANALYSIS EVEN WHILE SUPPORTED INDEPENDENTLY BY EITHER POWER LEAD. THE SYSTEM CONTROLLER WAS UNABLE TO BE ATTRIBUTED TO THE EVENTS CONTAINED WITHIN THE LOG FILE. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT AUDIBLE AND VISUAL LOW FLOW AND RED HEART ALARMS WERE BEING EXPERIENCED BY THE PATIENT. LOG FILES WERE SENT TO THE MANUFACTURER FOR REVIEW. THE SYSTEM CONTROLLER WAS EXCHANGED WITH ANOTHER SYSTEM CONTROLLER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179746 HEARTMATE II SYSTEM CONTROLLER DSQ: LAD SYSTEM CONTROLLER DSQ THORATEC CORP. 103695 112728

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention