BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 3973580 · Received August 1, 2014

    Report

    Report Number
    3007042319-2014-00786
    Event Type
    Death
    Date Received
    August 1, 2014
    Date of Event
    June 17, 2014
    Report Date
    July 3, 2014
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS AVAILABLE FOR EVALUATION, BUT HAS NOT BEEN RECEIVED BY THE MANUFACTURER. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY (30) DAYS OF RECEIPT. PRODUCT IS IN ROUTE.

    Additional Manufacturer Narrative · 1

    THE HEARTWARE VAD IS USED FOR TREATMENT NOT DIAGNOSIS. THE PUMP WAS RETURNED FOR EVALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICE IN RELATION TO THE REPORTED EVENT. THOROUGH EXTERNAL VISUAL INSPECTION OF THE DEVICE REVEALED NO SIGNS OF PHYSICAL DAMAGE OR CONTAMINATION. REVIEW OF THE MANUFACTURING DOCUMENTATION CONFIRMED THAT THE ASSOCIATED DEVICES MET ALL REQUIREMENTS FOR RELEASE. THE REPORTED EVENT WAS CONFIRMED VIA REVIEW OF THE CONTROLLER LOG FILES, WHICH REVEALED A CONTROLLER POWER UP AND MOTOR START ON THE DATE OF THE REPORTED EVENT. LOG FILE ANALYSIS REVEALED A DATA GAP OF 30 MINUTES, IN WHICH A CONTROLLER POWER UP AND MOTOR START WAS LOGGED. THE TIME BETWEEN THE LAST DATA POINT AND FIRST CONTROLLER POWER UP EVENT INDICATES THAT THE PUMP WAS OFF FOR AT LEAST 10 MINUTES WITH A MAXIMUM POSSIBLE PUMP OFF TIME OF 24 MINUTES. FURTHERMORE, IT WAS NOTED THAT THE LAST DATA POINT CAPTURED INDICATED THAT THE CONTROLLER WAS CONNECTED TO A BATTERY ON POWER SOURCE 1 AND AN AC ADAPTER ON POWER SOURCE 2. WHEN THE CONTROLLER POWER UP AND MOTOR START OCCURRED, POWER SOURCE 2 WAS CONNECTED TO A BATTERY. IT WAS STATED IN THE EVENT DETAILS THAT THE PATIENT WAS FOUND WITH BOTH POWER SOURCES DISCONNECTED. UPON ARRIVAL OF THE EMERGENCY MEDICAL RESPONSE TEAM, TWO BATTERIES WERE RECONNECTED AND A SUCCESSFUL PUMP START OCCURRED. A POSSIBLE EXPLANATION OF THE EVENTS THAT TRANSPIRED WAS THAT; AS THE PATIENT WAS SWITCHING THE AC ADAPTER ON POWER SOURCE 2 FOR A BATTERY SOURCE, THE PATIENT ACCIDENTALLY DISCONNECTED THE BATTERY ON POWER SOURCE 1, WHICH RESULTED IN A CONTROLLER LOSS OF POWER. AS THE PATIENT WAS ATTEMPTING TO RECONNECT TO A POWER SOURCE, THE PATIENT MAY HAVE EXPERIENCED AN ADVERSE EVENT AND SUBSEQUENTLY COLLAPSED. THE DISCONNECTION OF BOTH POWER SOURCES HAPPENED WITHIN A 10 SECOND PERIOD AS THERE WERE NO POWER DISCONNECT ALARMS LOGGED IN THE CONTROLLER LOG FILE. ANALYSIS OF THE RETURNED PUMP SHOWED THAT THE DEVICE MET SPECIFICATIONS. BASED ON THE LIMITED INFORMATION AVAILABLE, THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT CANNOT BE CONCLUSIVELY DETERMINED; A POSSIBLE ROOT CAUSE IS THE USER ACCIDENTALLY DISCONNECTING BOTH POWER SOURCES DURING A POWER SOURCE CHANGE. THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. THE VENTRICULAR ASSIST SYSTEM IS INDICATED FOR USE AS A BRIDGE TO CARDIAC TRANSPLANTATION IN PATIENTS WHO ARE AT RISK OF DEATH FROM REFRACTORY END-STAGE LEFT VENTRICULAR HEART FAILURE. THE SYSTEM IS DESIGNED FOR IN-HOSPITAL AND OUT-OF-HOSPITAL SETTINGS. PER THE INSTRUCTIONS FOR USE (IFU): PATIENTS ARE INSTRUCTED TO ALWAYS KEEP A BACK-UP CONTROLLER AVAILABLE AT ALL TIMES, BEYOND THE PRIMARY CONTROLLER THAT IS CURRENTLY IN USE. PATIENTS ARE INSTRUCTED TO CONTACT THE TREATING FACILITY IF THEY RECEIVE ANY OF A LIST OF CERTAIN ALARMS. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. HEARTWARE IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER (B)(4), DATED (B)(4) 2014, AND PURSUANT TO THE PROVISIONS OF 21 CFR PART 803.

    Description of Event or Problem · 1

    APPROXIMATELY EIGHT MONTHS POST HVAD IMPLANTATION, THE PATIENT REPORTEDLY BECAME UNRESPONSIVE AFTER EXPERIENCING CARDIAC ARREST. THE FIRE DEPARTMENT ARRIVED FIRST ON THE SCENE AND BEGAN CARDIOPULMONARY RESUSCITATIVE EFFORTS. APPROXIMATELY TEN MINUTES LATER EMERGENCY MEDICAL SERVICES (EMS) ARRIVED AND RECONNECTED THE AC ADAPTER TO THE WALL AFTER NOTING THE PATIENT'S POWER SOURCES WERE NOT CONNECTED, RESTARTING THE PUMP. THE PATIENT WAS INTUBATED AND TRANSFERRED TO A NEARBY HOSPITAL. THE FOLLOWING DAY, SHE WAS TRANSFERRED TO HER IMPLANTING FACILITY WHERE COOLING THERAPY WAS INITIATED. ELECTROENCEPHALOGRAPHY (EEG) RESULTS REVEALED NON-CONVULSIVE STATUS EPILEPTICUS (NCSE) RELATED TO ANOXIC INJURY VS. NCSE OF UNKNOWN ETIOLOGY. THE PATIENT CONTINUED TO EXPERIENCED INTRACTABLE SEIZURES AND WAS SUBSEQUENTLY LOADED WITH KEPPRA. THE SEIZURES WERE FINALLY CONTROLLED AFTER FOUR DEFIBRILLATIONS AND ADMINISTRATION OF PROPOFOL THOUGH SHE WAS UNABLE TO BE WEANED FROM THE SEDATION DUE TO REPEAT SEIZURE EPISODES. THE MEDICAL TEAM DISCUSSED THE PATIENT'S POOR PROGNOSIS WITH THE FAMILY AND THE DECISION WAS MADE TO DISCONNECT THE PATIENT'S INTERNAL CARDIOVERTER DEFIBRILLATOR (ICD) AND VAD AND CHANGE HER STATUS TO DO NOT RESUSCITATE/ DO NOT INTUBATE. THE PATIENT EXPIRED SHORTLY THEREAFTER. THE EXPLANTED PUMP WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451465 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Death