BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 3852931 · Received May 23, 2014

    Report

    Report Number
    2916596-2014-00823
    Event Type
    Death
    Date Received
    May 23, 2014
    Date of Event
    December 15, 2013
    Report Date
    April 24, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED SYSTEM CONTROLLER WAS SUBJECTED TO FULL FUNCTIONAL TESTING USING LABORATORY EQUIPMENT AND PASSED ALL TESTING. ALL AUDIO AND VISUAL SIGNALS WERE VERIFIED DURING THE TEST. THE SYSTEM CONTROLLER OPERATED FOR AN EXTENDED PERIOD OF TIME WHILE CONNECTED TO A MOCK CIRCULATORY LOOP WITH NO ABNORMAL EVENTS OR ALARMS NOTED. THE DATA LOG FILE WAS SUCCESSFULLY RETRIEVED AND CONTAINED APPROXIMATELY 35 DAYS OF EVENTS, FROM (B)(6) TO (B)(6) 2013. THE INFORMATION RECORDED ON (B)(6) AT 12:24 PM INDICATED THAT THE CONTROLLER WAS CONNECTED TO 14V LI-ION BATTERIES. THE DATA RECORDED ON (B)(6) AT 0118 AM SUGGESTS AN INTERMITTENT CONNECTION WITH ONE POWER CABLE WHICH RESULTED IN MULTIPLE POWER CABLE DISCONNECT ALARMS. THE INVESTIGATION WAS UNABLE TO DETERMINE WHAT MAY HAVE CAUSED THE INTERMITTENT CONNECTION. BASED ON THE INFORMATION, THE SYSTEM WAS SUPPORTED BY ONE POWER CABLE CONNECTED TO A 14V BATTERY UNTIL 03:23 AM WHEN THE SYSTEM CONTROLLER ACTIVATED A LOW BATTERY ADVISORY ALARM. AT 04:28 AM, THE ALARM PROGRESSED TO A LOW BATTERY HAZARD ALARM AND THERE WAS A POWER SAVE MODE RECORDED. THE LAST RECORDED ENTRY, AT 04:44 AM, INDICATED THAT THE SYSTEM WAS SUPPORTED BY THE CONTROLLER INTERNAL BACKUP BATTERY AND THERE WERE LOW BATTERY HAZARD AND NO EXTERNAL POWER ALARMS ACTIVE. A REVIEW OF DEVICE HISTORY RECORDS FOR THIS DEVICE SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    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 MFR'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED THAT THE PT WAS FOUND DECEASED AT HOME BY FAMILY MEMBERS. THE PERCUTANEOUS LEAD (DRIVELINE) AND POWER SOURCES WERE CONNECTED AT THE TIME THE PT WAS DISCOVERED AND NO ALARMS WERE SOUNDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308478 HEARTMATE II SYSTEM CONTROLLER DSQ: LVAD SYSTEM CONTROLLER DSQ THORATEC CORP. 106762 128091

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death