BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 4931636 · Received July 22, 2015

    Report

    Report Number
    3007042319-2015-01481
    Event Type
    Death
    Date Received
    July 22, 2015
    Date of Event
    July 5, 2015
    Report Date
    July 5, 2015
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HEARTWARE VAD IS USED FOR TREATMENT NOT DIAGNOSIS. CONTROLLER ((B)(4)) 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 DEVICE MET ALL REQUIREMENTS FOR RELEASE. LOG FILE REVIEW REVEALED NO OCCURRENCES OF HIGH PRIORITY ALARMS ON THE EVENT DATE. THE CONTROLLER PASSED VISUAL INSPECTION BUT FAILED FUNCTIONAL TESTING. THE NO POWER ALARM REMAINED SILENT WHEN BOTH POWER SOURCES WERE DISCONNECTED FROM THE CONTROLLER, THUS CONFIRMING THE REPORTED EVENT. THE CONTROLLER NIMH INTERNAL BATTERY THAT SUPPLIES POWER FOR THE NO POWER ALARM WAS FOUND DEPLETED. FURTHER ANALYSIS REVEALED A FAULTY INTERNAL BATTERY CELL. THE CONFIRMED MALFUNCTION IS RELATED TO THE REPORTED EVENT. A POSSIBLE ROOT CAUSE OF THE "NO POWER" EVENT WAS AN ACCIDENTAL DISCONNECTION OF BOTH POWER SOURCES BY THE PATIENT DURING A POWER SOURCE CHANGE. THE MOST LIKELY ROOT CAUSE OF THE REPORTED "NO SOUND" EVENT IS A FAULTY INTERNAL NICKEL-METAL HYDRIDE (NIMH) BATTERY INSIDE THE CONTROLLER. THERE ARE NO KNOWN CLINICAL OR USER FACTORS THAT COULD HAVE CONTRIBUTED TO THIS EVENT. THE MANUFACTURER HAS OPENED AN INTERNAL INVESTIGATION TO EVALUATE THESE TYPES OF ISSUES. 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, INCLUDING TRANSPORTATION. 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.

    Description of Event or Problem · 1

    THE VENTRICULAR ASSIST DEVICE (VAD) COORDINATOR REPORTED THAT THE PATIENT WAS FOUND DECEASED AT HOME WITH NO POWER SOURCES CONNECTED. ADDITIONAL INFORMATION RECEIVED VIA THE CLINICAL DATABASE REPORTED THE CONTROLLER'S LAST RECORDED POWER CONSUMPTION AND ESTIMATED FLOW WAS AT 3:03 AM ON (B)(6) 2015. THE PATIENT'S WIFE WOKE UP AROUND 4:00AM AND DISCOVERED THE PATIENT UNRESPONSIVE. THE PATIENT WAS NOT CONNECTED TO ANY POWER SOURCES BUT THE DRIVELINE REMAINED CONNECTED TO THE CONTROLLER. THE WIFE DENIED HEARING ANY ALARMS. THE CONTROLLER WAS SHIPPED BACK TO THE SITE AND THEN RETURNED TO HEARTWARE FOR FURTHER EVALUATION. THE VAD COORDINATOR RECREATED THE NO POWER SCENARIO AND CONFIRMED THAT NO ALARMS SOUNDED. IT IS UNKNOWN WHY THE PATIENT WAS DISCONNECTED FROM POWER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474955 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Death