BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 5099575 · Received September 24, 2015

    Report

    Report Number
    3007042319-2015-02279
    Event Type
    Death
    Date Received
    September 24, 2015
    Date of Event
    September 14, 2015
    Report Date
    September 15, 2015
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT'S PUMP WAS RESTARTED APPROXIMATELY FIFTEEN MINUTES LATER BY AN EMERGENCY ROOM DOCTOR. THE PATIENT WAS STILL UNCONSCIOUS AND WAS TRANSFERRED TO THE NEAREST FACILITY FOR TREATMENT. THAT NIGHT THE FAMILY DECIDED TO CEASE VENTILATION AND TURN THE PUMP OFF. AN AUTOPSY WAS PERFORMED. THE OFFICIAL CAUSE OF DEATH WAS REPORTED TO BE HYPOXIC BRAIN DAMAGE. THE THERAPEUTIC TEAM BELIEVES THAT DRIVELINE CABLE MAY NOT HAVE BEEN PROPERLY CONNECTED TO THE CONTROLLER. INVESTIGATION IS ONGOING. THIS IS ONE OF TWO REPORTS (3007042319-2015-02279 AND 3007042319-2015-02280) SUBMITTED FOR DEVICES RELATED TO THE SAME EVENT. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 1

    LOG FILE ANALYSIS: REVIEW OF THE CONTROLLER LOG FILES ASSOCIATED WITH THE EVENT REVEALED THAT (B)(4) LOGGED A TOTAL OF 12 ELECTRICAL FAULTS BETWEEN (B)(6) 2015. ALL ELECTRICAL FAULTS ON (B)(6) 2015 INDICATED MOTOR DISCONNECTION AND WERE FOLLOWED BY VAD DISCONNECT ALARMS. THE LAST RUNNING DATA POINT PRIOR EVENT WAS LOGGED BY (B)(4) ON (B)(6) 2015 AT 20:44 AND THE FIRST MOTOR START WAS LOGGED BY (B)(4) ON THE SAME DAY AT 21:00 INDICATING THAT PUMP OFF TIME MIGHT HAVE BEEN ANY TIME BETWEEN 0 TO 15 MINUTES. ALARMS LOGGED ON (B)(6) 2015 MAY BE INDICATIVE OF LOOSE CONNECTION BETWEEN DRIVELINE AND CONTROLLER. A REVIEW OF THE DEVICES' MANUFACTURING RECORDS INDICATED THERE WERE NO NCMRS GENERATED THAT COULD BE RELATED TO THE REPORTED EVENT. UPON COMPLETION OF THE REVIEW, IT WAS CONCLUDED THAT THE UNIT MET THE INTERNAL REQUIREMENTS PRIOR TO ITS QUALITY ASSURANCE RELEASE PROCESS. (B)(4) WAS NOT RETURNED FOR EVALUATION. 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 "ELECTRICAL FAULT" AND "VAD DISCONNECT" ALARMS. THE DEVICE LABELING WARNS THAT DISCONNECTING THE CONTROLLER FROM THE DRIVELINE WILL RESULT IN A "VAD STOPPED" ALARM IF THE PUMP DRIVELINE IS NOT CONNECTED TO A CONTROLLER WITHIN TEN SECONDS. THIS ALARM WILL RESOLVE ONCE THE PUMP DRIVELINE IS CONNECTED TO A NEW CONTROLLER. BASED ON THE AVAILABLE INFORMATION THE PATIENT'S PUMP WAS NOT RESTARTED UNTIL FIFTEEN MINUTES LATER AFTER SUCCESSFUL RECONNECTION TO THE PATIENT'S BACK UP CONTROLLER. THE INTERRUPTION OF THE FLOW OF OXYGEN TO THE BRAIN (WHICH WOULD LIKELY OCCUR DURING THIS PERIOD OF TIME) CAN POTENTIALLY LEAD TO STROKE, CARDIAC ARREST, AND AN IRREGULAR HEARTBEAT DUE INSUFFICIENT OXYGEN AND NUTRIENTS TO THE BODY'S VITAL ORGANS. IN THIS CASE, IT RESULTED IN NEUROLOGICAL DYSFUNCTION, AND ULTIMATELY DEATH OF THE PATIENT. BASED ON THE AVAILABLE INFORMATION THE MOST LIKELY ROOT CAUSE OF THE PATIENT OUTCOME IS HYPOPERFUSION TO THE BRAIN AS A RESULT OF THE LOSS OF POWER WHICH LEAD TO HYPOXIC BRAIN INJURY. THERE ARE PATIENT AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. THIS IS ONE OF TWO REPORTS (3007042319-2015-02279 AND 3007042319-2015-02280) SUBMITTED FOR DEVICES RELATED TO THE SAME EVENT.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE CONTROLLER LOG FILES ASSOCIATED WITH THE EVENT CAPTURED, REVEALED THAT CONTROLLER LOGGED A TOTAL OF (B)(4) ELECTRICAL FAULTS BETWEEN SEPTEMBER 12 AND SEPTEMBER 14, 2015. ALL ELECTRICAL FAULTS ON SEPTEMBER 14, 2015 INDICATED MOTOR DISCONNECTION AND WERE FOLLOWED BY VAD DISCONNECT ALARMS. THE LAST RUNNING DATA POINT PRIOR EVENT WERE LOGGED ON SEPTEMBER 14, 2015. 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) AND PATIENT MANUAL: INCLUDE A REFERENCE GUIDE FOR BOTH VISUAL AND TONE ALARMS INCLUDING POTENTIAL CAUSES AND ACTIONS TO TAKE. ALSO STATED, CONTROLLER AND POWER MANAGEMENT AND A QUICK REFERENCE GUIDE FOR ALARMS INCLUDING POTENTIAL CAUSES AND ACTIONS TO TAKE. ADDITIONALLY THERE IS A WARNING TO KEEP SPARE, FULLY CHARGED BATTERIES AND BACK UP CONTROLLER AVAILABLE AT ALL TIME. IFU STATES; FAILURE TO ENSURE A SECURE CONNECTION BETWEEN THE CONTROLLER AND DRIVELINE MAY CAUSE AN ELECTRICAL FAULT. ALSO STATED IN IFU, A FAULT IN THE CONTINUITY OF THE PUMP TO CONTROLLER ELECTRICAL CONNECTION TRIGGERS E-FAULT ALARM. THE INSTRUCTIONS FOR USE (IFU) ADDRESSES GUIDELINES FOR OPTIMAL PATIENT MANAGEMENT (INCLUDING THERAPEUTIC ANTICOAGULATION GUIDELINES). ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE VAD INCLUDE WARNING OF SERIOUS AND LIFE THREATENING ADVERSE EVENTS, SUCH AS NEUROLOGIC DYSFUNCTION AND DEATH. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. MISSING INFORMATION FROM THIS REPORT WAS NOT PROVIDED IN THE REPORTED EVENT OR AVAILABLE AT THE TIME OF REPORT SUBMISSION. THE COMPANY IS SEEKING THIS INFORMATION THROUGH THE EVENT INVESTIGATION. THIS IS ONE OF TWO REPORTS (3007042319-2015-02279 AND 3007042319-2015-02280) SUBMITTED FOR DEVICES RELATED TO THE SAME EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM (B)(6) ON (B)(6) 2015, THAT THE "PATIENT CALLED THE VAD-TEAM WHILE HAVING E-FAULTS." "WHILE PATIENT WAS TALKING TO THE VAD-COORDINATOR, THE PUMP STOPPED." "PUMP RESTARTED SUCCESSFULLY AFTER CHANGING TO THE BACKUP CONTROLLER." PATIENT SUFFERED NEUROLOGICAL DYSFUNCTION AND SUBSEQUENTLY EXPIRED ON (B)(6) 2015, WHILE IN THE ICU. THIS IS REPORT 1 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633809 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death