BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 3902115 · Received May 6, 2014

    Report

    Report Number
    2916596-2014-00715
    Event Type
    Malfunction
    Date Received
    May 6, 2014
    Date of Event
    April 9, 2014
    Report Date
    April 9, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, 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. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    THE REPORTED INCIDENT OF A CONTINUOUS AUDIBLE ALARM WITHOUT ANY VISUAL ILLUMINATION WAS CONFIRMED BASED ON THE EVALUATION OF THE RETURNED DEVICE. DURING ANALYSIS, THE SYSTEM CONTROLLER WAS CONNECTED TO THE MANUFACTURER'S LABORATORY EQUIPMENT AND WAS UNABLE TO OPERATE THE TEST LVAD. THE DEVICE WAS UNRESPONSIVE AND HAD A CONTINUOUS AUDIBLE TONE. THE EVALUATION OF THE DEVICE REVEALED DAMAGED/SHORTED COMPONENTS RESULTING IN THE DISRUPTION OF THE MAIN VOLTAGE SUPPLY TO SEVERAL COMPONENTS. THE ANALYSIS COULD NOT DETERMINE THE SPECIFIC ROOT CAUSE OF THE DAMAGED/SHORTED COMPONENTS. A REVIEW OF DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: THE PATIENT WAS SLIDING DOWN A PLASTIC SLIDE WHEN HE STARTED TO HAVE ISSUES WITH THE SYSTEM CONTROLLER AND IT STARTED ALARMING. THE PATIENT REPORTEDLY NOTED STATIC ELECTRICITY AT THE TIME HE WAS GOING DOWN THE SLIDE. THE PATIENT'S DRIVELINE WAS CHECKED TO MAKE SURE THERE WERE NO NOTICEABLE FRACTURES. THE PATIENT HAD NO FURTHER ALARMS AFTER THE SYSTEM CONTROLLER EXCHANGE. THE PATIENT WAS KEPT OVERNIGHT BECAUSE HIS INTERNATIONAL NORMALIZED RATIO (INR) WAS SUB-THERAPEUTIC AT 1.2. IT WAS SUSPECTED THAT THE STATIC ELECTRICITY MAY HAVE AFFECTED A SYSTEM CONTROLLER COMPONENT.

    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 SYSTEM CONTROLLER HAD AN ABRUPT ALARM WITH CONTINOUS TONE AND LOSS OF ALL LIGHTS. THE SYSTEM CONTROLLER WAS EXCHANGED WITH ANOTHER SYSTEM CONTROLLER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271778 HEARTMATE II SYSTEM CONTROLLER DSQ: LVAD SYSTEM CONTROLLER DSQ THORATEC CORP. 103696 124620

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention