BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 4950761 · Received July 29, 2015

    Report

    Report Number
    3007042319-2015-01664
    Event Type
    Death
    Date Received
    July 29, 2015
    Date of Event
    July 20, 2015
    Report Date
    July 21, 2015
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HEARTWARE VAD 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, INCLUDING TRANSPORTATION. THE INSTRUCTIONS FOR USE AND PATIENT MANUAL INCLUDE A REFERENCE GUIDE FOR BOTH VISUAL AND TONE ALARMS AND ASSOCIATED CAUSES AND ACTIONS TO TAKE. THERE IS A WARNING TO KEEP A SPARE SET OF FULLY CHARGED BATTERIES AND A SPARE BACK UP CONTROLLER AVAILABLE AT ALL TIMES. THE STEPS FOR EXCHANGE OF DEVICES ARE ALSO OUTLINED. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. THIS IS FOUR OF FOUR REPORTS (3007042319-2015-01661, 2015-01662, 2015-01663 AND 2015-01664) SUBMITTED FOR DEVICES RELATED TO THE SAME EVENT. PRODUCT IS IN ROUTE.

    Additional Manufacturer Narrative · 1

    TWO CONTROLLERS, SEVEN BATTERIES, TWO CAC ADAPTERS AND A PUMP WERE RETURNED FOR EVALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICES IN RELATION TO THE REPORTED EVENT. LOG FILE ANALYSIS DID NOT REVEAL ANY ALARMS PRIOR TO THE REPORTED EVENT. AN OBSERVATION DURING LOG FILE ANALYSIS REVEALED PREMATURE POWER SWITCHING EVENTS. ANALYSIS OF THE BACK-UP CONTROLLER DID NOT REVEAL A CONTROLLER POWER UP OR MOTOR START EVENT. THIS INDICATES THAT THE PATIENT, OR RELATIVE, DID NOT ATTEMPT TO PERFORM A CONTROLLER-EXCHANGE. LOG FILE ANALYSIS ON (B)(4) (PRIMARY CONTROLLER) DID NOT REVEAL ANY ALARMS THAT WERE LOGGED PRIOR TO THE LOSS OF POWER. THE LAST DATA POINT WAS LOGGED ON (B)(4) 2015 AT 21:07:03; A CONTROLLER AC ADAPTER ON POWER PORT 1 AND A BATTERY (B)(4) AT 85% RSOC ON POWER PORT 2. NO CONTROLLER POWER UPS OR MOTOR STARTS WERE LOGGED. ANALYSIS OF BATTERY (B)(4) REVEALED THAT THE BATTERY FAILED TO MEET SPECIFICATIONS; A HIGH MAX ERROR WAS FOUND DURING TESTING, INDICATIVE THAT THE BATTERY ARE OUT OF CALIBRATION. LOG FILE ANALYSIS REVEALED A USAGE PATTERN WHERE THE BATTERIES WERE BEING EXCHANGED AND RECHARGED AT LEVELS ABOVE THE RECOMMENDED 25 % RELATIVE STATE OF CHARGE (RSOC). THIS FINDING DOES NOT IMPACT THE FUNCTIONALITY OF THE BATTERY TO PERFORM APPROPRIATELY. THE ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO A SHORTED POWER MOSFET ON THE POWER BOARD. THIS ISSUE IS CURRENTLY BEING INVESTIGATED. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. THIS IS ONE OF FOUR REPORTS (3007042319-2015-01661, 2015-01662, 2015-01663 AND 2015-01664) SUBMITTED FOR DEVICES RELATED TO THE SAME EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE VENTRICULAR ASSIST DEVICE (VAD) COORDINATOR THAT THE PATIENT WAS STAYING AT HIS MOTHER IN LAW'S HOUSE, WHO WAS NOT FORMALLY TRAINED IN VAD EMERGENCY MANAGEMENT. THE MOTHER-IN-LAW REPORTED THAT THE PATIENT WAS WATCHING TELEVISION ON (B)(6) 2015, WHEN HE SUDDENLY YELLED "BATTERIES!" HIS SON RAN AND GOT THE BACKUP EQUIPMENT AND THEY CHANGED THE EQUIPMENT. THE ALARM DID NOT STOP AND THE PATIENT PASSED OUT. CPR WAS PERFORMED BY THE SON UNTIL THE AMBULANCE ARRIVED. THE PARAMEDICS CONTINUED CPR BUT THEY THEN STOPPED WHEN THE POLICE ARRIVED. THE PATIENT WAS NOT TAKEN TO HOSPITAL. THE DEATH HAS BEEN REFERRED TO THE STATE CORONER'S OFFICE. RETURN OF THE PUMP WITH ALL EQUIPMENT HAS BEEN REQUESTED BY THE VAD COORDINATOR. IT WAS NOT REPORTED WHAT "BACKUP EQUIPMENT" WAS USED; WHETHER ONLY SPARE BATTERIES OR THE BACKUP CONTROLLER WAS ALSO RELATED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493854 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Death UNK_BATTERY| UNK_BATTERY