BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 4920424 · Received July 16, 2015

    Report

    Report Number
    3007042319-2015-01487
    Event Type
    Death
    Date Received
    July 16, 2015
    Date of Event
    May 8, 2015
    Report Date
    June 16, 2015
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), TWO CONTROLLERS, FOUR BATTERIES, CAC ADAPTER, BATTERY CHARGER, AND BAC ADAPTER WERE RETURNED FOR EVALUATION. REVIEW OF THE MANUFACTURING DOCUMENTATION OF (B)(4) CONFIRMED THAT THE ASSOCIATED DEVICE MET ALL REQUIREMENTS FOR RELEASE. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICES IN RELATION TO THE REPORTED EVENT. ANALYSIS OF THE DEVICES REVEALED THAT (B)(4) FAILED TO MEET SPECIFICATIONS; THE DEVICE PASSED VISUAL EXAMINATION BUT FAILED FUNCTIONAL TESTING DUE TO A LEAKY NIMH BATTERY THAT RESULTED IN THE FAILURE OF THE NO POWER ALARM. THE CONFIRMED MALFUNCTION IS RELATED TO THE REPORTED EVENT. HEARTWARE HAS OPENED AN INTERNAL INVESTIGATION TO FURTHER INVESTIGATE THIS ISSUE. (B)(4) PASSED VISUAL EXAMINATION AND FUNCTIONAL/DIMENSIONAL TESTING AS WELL AS PATHOLOGICAL EVALUATION. ANALYSIS OF (B)(4) REVEALED THAT THE CONTROLLER MET SPECIFICATIONS; THE DEVICE PASSED VISUAL EXAMINATION AND FUNCTIONAL TESTING. (B)(4) MET SPECIFICATIONS; THE DEVICES PASSED VISUAL EXAMINATION AND FUNCTIONAL TESTING. LOG FILE REVIEW REVEALED THESE BATTERIES WERE INVOLVED IN POWER SWITCHING EVENTS PRIOR TO THE REPORTED EVENT. THIS IS AN INCIDENTAL FINDING AND DID NOT CONTRIBUTE TO THE REPORTED LOSS OF POWER. THE REPORTED DOUBLE DISCONNECT OF POWER SOURCES WAS CONFIRMED VIA LOG FILE ANALYSIS WHICH REVEALED A MAXIMUM LOSS OF POWER OF 2 HOURS AND 26 MINUTES ON THE REPORTED EVENT DATE. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE MADE BUT WERE UNSUCCESSFUL. HOWEVER, WHILE THERE IS NO DEFINITIVE CAUSE OF THE POWER DISCONNECT, THERE IS NO INDICATION THAT THERE WERE ANY DEVICE ISSUES THAT COULD HAVE CAUSED IT. FURTHERMORE, THE DEVICE LABELING WARNS THAT DISCONNECTING THE CONTROLLER FROM THE DRIVELINE AND DISCONNECTING BOTH POWER SOURCES (BATTERIES AND AC OR DC ADAPTER) AT THE SAME TIME WILL STOP THE PUMP. AT LEAST ONE POWER SOURCE MUST BE CONNECTED AT ALL TIMES. THE MOST LIKELY ROOT CAUSE OF THE LOSS OF POWER IS A DOUBLE DISCONNECTION OF POWER SOURCES FROM THE CONTROLLER. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 1

    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. SERIOUS AND LIFE THREATENING ADVERSE EVENTS, INCLUDING DEATH AND BLEEDING HAVE BEEN ASSOCIATED WITH USE OF THIS DEVICE AS OUTLINED IN THE INSTRUCTIONS FOR USE (IFU). WHILE THERE IS NO EVIDENCE BASED ON THE AVAILABLE INFORMATION, IT MAY BE POSSIBLE THAT THERE WERE SOME UNDERLYING HEALTH CONDITIONS THAT COULD HAVE PREDISPOSED THE PATIENT TO THIS EVENT. CURRENTLY, FROM ALL INDICATIONS THE DEVICE OPERATED WITHIN SPECIFICATIONS AND AS INTENDED WITH NO INDICATION OF ANY DEVICE PERFORMANCE ISSUES CONTRIBUTING TO THE EVENT. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. THE COMPANY IS SEEKING THIS INFORMATION THROUGH THE EVENT INVESTIGATION. CURRENT DEVICE LOCATION IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM SWITZERLAND BY THE VAD COORDINATOR THAT THE PATIENT WAS ADMITTED TO THE REHAB CENTER ON (B)(6). ON THE MORNING OF (B)(6), A NURSE FOUND THE PATIENT DEAD, LYING ON HIS BED AT THE REHAB CENTER. THE AC ADAPTER WAS NOT CONNECTED ON THE CONTROLLER AND THE BATTERY WAS ALSO NOT CONNECTED. THE NURSE NOTED THAT THE AC ADAPTER WAS ALSO NOT CONNECTED TO THE WALL PLUG. LOG FILES HAVE BEEN RECEIVED BY THE MANUFACTURER FOR ANALYSIS. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. INVESTIGATION IS IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463049 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC 1104

    Patients

    Seq Age Sex Outcome Treatment
    1 Death