BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 3983373 · Received July 7, 2014

    Report

    Report Number
    2916596-2014-01125
    Event Type
    Malfunction
    Date Received
    July 7, 2014
    Date of Event
    March 19, 2014
    Report Date
    June 6, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT OF ¿RED HEART¿ ALARMS AND PUMP STOPPAGES WAS CONFIRMED BASED ON THE INFORMATION RECORDED IN THE LOG FILE; HOWEVER, THE EVENTS COULD NOT BE REPRODUCED DURING THE INVESTIGATION. THE DATA LOG FILE WAS SUCCESSFULLY RETRIEVED AND CONTAINED APPROXIMATELY 15 DAYS OF EVENTS, FROM (B)(6) 2014 TO (B)(6) 2014 (ACCORDING TO THE TIME STAMP). THE LOG FILE APPEARED TO CAPTURE THE INITIALIZATION OF THE SYSTEM CONTROLLER. ON (B)(6) 2014 AND (B)(6) 2014, MULTIPLE TRANSIENT PUMP STOPPAGES AND REDUCTIONS IN PUMP SPEED BELOW THE LOW SPEED LIMIT WERE CAPTURED. POWER ELEVATIONS IN THE 10.9 TO 24.9 WATT RANGE WERE RECORDED DURING THESE EVENTS. THE END OF THE LOG FILE CAPTURED THE DRIVELINE BEING DISCONNECTED AND THE SYSTEM CONTROLLER BEING POWERED DOWN. THE RETURNED SYSTEM CONTROLLER PASSED FUNCTIONAL TESTING AND OPERATED A TEST PUMP FOR AN EXTENDED PERIOD OF TIME WITHOUT ANY ISSUES, FUNCTIONING AS DESIGNED DURING THE INVESTIGATION. THE REPORTED EVENTS OF PUMP STOPPAGES COULD NOT BE LINKED TO THE RETURNED SYSTEM CONTROLLER AND THE ROOT CAUSE OF THE EVENTS COULD NOT BE CONCLUSIVELY DETERMINED. A REVIEW OF DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE 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.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED THAT THE SYSTEM CONTROLLER DISPLAYED A RED HEART ALARM. IT WAS REPORTED THAT THE SYSTEM CONTROLLER WAS REPLACED WHILE TROUBLESHOOTING FOR PUMP STOPPAGES. THE SYSTEM CONTROLLER WILL BE RETURNING FOR EVAL. THERE WAS NO INDICATION THAT THE REPORTED ISSUE CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394919 HEARTMATE II SYSTEM CONTROLLER LVAD SYSTEM CONTROLLER DSQ THORATEC CORP. 106762 138578

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR