BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 3870377 · Received June 2, 2014

    Report

    Report Number
    2916596-2014-00879
    Event Type
    Death
    Date Received
    June 2, 2014
    Date of Event
    March 24, 2014
    Report Date
    May 3, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT WAS INITIALLY REPORTED ON THE PUMP (REFERENCE MFR REPORT # 2916596-2014-00628); HOWEVER, DURING THE EVAL OF THE SYSTEM CONTROLLER, THE CONTROLLER DID NOT OPERATE THE PUMP. THE SYSTEM CONTROLLER WAS RETURNED TO THE MFR FOR EVAL, AND THE ANALYSIS CONFIRMED A RELATIONSHIP BETWEEN THE RETURNED SYSTEM CONTROLLER AND THE REPORTED EVENT OF A LOW FLOW MESSAGE ON THE DISPLAY MODULE. DURING ANALYSIS, THE SYSTEM CONTROLLER WAS CONNECTED TO THE LABORATORY EQUIPMENT AND WAS UNABLE TO OPERATE THE TEST LVAD AS REC'D. ALSO, A LOW FLOW ALARM WAS DISPLAYED ON THE SYSTEM MONITOR AND A RED HEART VISUAL ALARM DISPLAYED ON THE FRONT PANEL OF THE SYSTEM CONTROLLER. THE EVAL OF THE DEVICE REVEALED A SHORT CIRCUIT CONDITION WITHIN A COMPONENT THAT DAMAGED A FUSE FOR THE MAIN VOLTAGE REGULATOR, RESULTING IN THE PUMP TO STOP. THE ANALYSIS COULD NOT DETERMINE WHAT CONTRIBUTED TO THE SHORT CIRCUIT CONDITION OF THE COMPONENT. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED THE DEVICE MET ALL APPLICABLE SPECIFICATIONS UPON PRODUCT RELEASE. NO FURTHER INFO IS AVAILABLE. THE MFR IS CLOSING ITS FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED THAT THE PT HAD BEEN OUT WITH A FRIEND FOR SUPPER AND WHEN SHE ARRIVED AT HER SISTER'S HOUSE, AND AUDIBLE ALARM WERE HEARD. WHEN THE PT ARRIVED AT THE HOUSE SHE STATED THAT SHE NEEDED TO CHANGE HER SYSTEM CONTROLLER. WHILE THE PT SAT DOWN ON THE COUCH THE PT'S SISTER INDICATED THAT THE PT EXPERIENCED SHORTNESS OF BREATH AND SWEATINESS. THE PT DID NOT GET HER FIRST BATTERY CHANGED TO THE NEW SYSTEM CONTROLLER BEFORE SHE PASSED OUT. IT WAS REPORTED THAT THE PT'S FAMILY WENT INTO THE BEDROOM AND FOUND THAT THE PT WAS ON THE FLOOR. AT THIS TIME, THE PT'S SISTER CONTACTED EMERGENCY MEDICAL SERVICES (EMS) AND HER BROTHER-IN-LAW CALLED THE PT'S MOTHER FOR HELP. THE BROTHER-IN-LAW RAN DOWNSTAIRS TO GET THE POWER MODULE AND BROUGHT IT TO THE PT. THE BROTHER-IN-LAW HOOKED THE PT UP AND THE DISPLAY MODULE WAS READING "LOW FLOW." IT WAS REPORTED THAT NEITHER THE SISTER AND BROTHER-IN-LAW KNEW HOW TO CHANGE-OUT THE SYSTEM CONTROLLER, NOR DID THEY GET INSTRUCTIONS FROM THE PT'S MOTHER OR THE MFR FOR ASSISTANCE. THE PT WAS APNEIC AND "PULSELESS" WHEN THE FIRST RESPONDER ARRIVED. THE FIRST RESPONDER LISTENED OVER THE PUMP AND DID NOT HEAR HEART TONES OR THE PUMP. NO CPR WAS PERFORMED AT THE SCENE. AIRWAY AND IV ACCESS WERE ESTABLISHED BEFORE THE AMBULANCE ARRIVED (WHICH WAS ABOUT 18 MINS FROM THE TIME THE FIRST RESPONDER CALLED ANOTHER MEMBER). THE PT COULD NOT BE REVIVED AND WAS TAKEN TO A LOCAL HOSPITAL AND WAS PRONOUNCED DEAD. AN AUTOPSY WAS NOT PERFORMED. DURING THE INVESTIGATION OF THE SYSTEM CONTROLLER, THE CONTROLLER DID NOT OPERATE THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322184 HEARTMATE II SYSTEM CONTROLLER DSQ: LVAD SYSTEM CONTROLLER DSQ THORATEC CORP. 103696

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Death