BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 4092521 · Received May 29, 2014

    Report

    Report Number
    2916596-2014-00865
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 1, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT SYSTEM CONTROLLER WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    THE RETURNED SYSTEM CONTROLLER WAS CONNECTED TO THE MANUFACTURER¿S LABORATORY TEST EQUIPMENT AND WAS UNABLE TO OPERATE THE TEST PUMP. THE SYSTEM CONTROLLER WAS UNRESPONSIVE AND THE RED HEART VISUAL ALARM WAS PULSING/FLICKERING. THE EVALUATION OF THE SYSTEM CONTROLLER REVEALED DAMAGED/SHORTED COMPONENTS RESULTING IN THE DISRUPTION OF THE MAIN VOLTAGE SUPPLY TO SEVERAL COMPONENTS. THE ANALYSIS COULD NOT DETERMINE THE SPECIFIC CAUSE OF THE DAMAGED/SHORTED COMPONENTS.A REVIEW OF DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS THAT WOULD AFFECT DEVICE FUNCTION OR PERFORMANCE. 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). APPROXIMATELY 2 YEARS POST-IMPLANT IT WAS REPORTED THAT THE PATIENT RECEIVED CONTINUOUS RED HEART ALARMS ON HER SYSTEM CONTROLLER AND WAS NOT ABLE TO MUTE THE ALARMS. THE PATIENT'S PERCUTANEOUS LEAD WAS CONNECTED AND THE BATTERIES WERE FULLY CHARGED. SHE WAS AWAY FROM HOME AND DIDN'T HAVE HER BACK-UP SYSTEM CONTROLLER OR BACK-UP BATTERIES WITH HER. AN AMBULANCE DOCTOR AUSCULTATED THE PATIENT'S CHEST AND CONFIRMED THAT THE PUMP WAS RUNNING. AT THE HOSPITAL, THE PERFUSIONIST CONNECTED THE SYSTEM CONTROLLER TO A SYSTEM MONITOR AND "PUMP OFF" WAS DISPLAYED. THE PERFUSIONIST SWITCHED TO ANOTHER SYSTEM CONTROLLER AND NORMAL PUMP VALUES WERE DISPLAYED. THE PATIENT WAS CONSCIOUS THE ENTIRE TIME AND NO EFFECTS TO THE PATIENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317530 HEARTMATE II SYSTEM CONTROLLER DSQ: LVAD SYSTEM CONTROLLER DSQ THORATEC CORP. 103692 113639

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention