BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 5468486 · Received February 29, 2016

    Report

    Report Number
    3007042319-2016-00918
    Event Type
    Death
    Date Received
    February 29, 2016
    Date of Event
    June 23, 2015
    Report Date
    June 23, 2015
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP, TWO CONTROLLERS, SIX BATTERIES, TWO CAC ADAPTERS, A BATTERY CHARGER, AND CDC ADAPTER 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. (B)(4) FAILED TO MEET SPECIFICATION; THE BATTERY PASSED VISUAL INSPECTION BUT FAILED FUNCTIONAL TESTING DUE TO A FAULTY CELL PAIR. HOWEVER, PRIOR TO THE FIRST LOSS OF POWER THIS BATTERY WAS CAPABLE OF PROVIDING POWER TO THE CONTROLLER AS WELL AS DURING BENCH TESTING. (B)(4) MET SPECIFICATIONS AS THEY PASSED BOTH VISUAL INSPECTION AND FUNCTIONAL TESTING. A REVIEW OF THE CONTROLLER LOGS REVEALED THAT MULTIPLE, NON-CONSECUTIVE, PREMATURE BATTERY SWITCHES OCCURRED DURING THE WEEKS PRIOR TO THE REPORTED EVENT. THE REPORTED LOSS OF POWER TO THE CONTROLLER WAS CONFIRMED VIA REVIEW OF LOG FILES, WHICH REVEALED 4 CONTROLLER POWER UP AND 3 MOTOR START EVENTS. THE CORRESPONDING PUMP OFF TIMES WERE APPROXIMATELY 5, 5, AND 17-32 MINUTES RESPECTIVELY. THESE ARE INDICATIVE THAT BOTH POWER SOURCES WERE DISCONNECTED FROM THE CONTROLLER AT THE SAME TIME. THE PREMATURE SWITCHING INCIDENTS NOTED IN THE LOGS COULD HAVE BEEN CAUSED BY A FAULTY CELL PAIR. (B)(4) MET SPECIFICATIONS AS THEY PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. (B)(4) MET SPECIFICATIONS AND PATHOLOGICAL EVALUATION DID NOT REVEAL ANY EVIDENCE OF DEVICE COMPLICATION OR THROMBUS FORMATION. THE MOST LIKELY ROOT CAUSE OF THE REPORTED LOSS OF POWER COULD POSSIBLY BE ATTRIBUTED TO MULTIFACTORIAL ISSUES SUCH AS THE DOUBLE DISCONNECTION OF THE BATTERIES FROM THE CONTROLLER OR THE FAULTY CELL WITHIN (B)(4). ADDITIONAL SYSTEM COMPONENT BEING REPORTED FOR THIS EVENT: CONTROLLER: (B)(4) - EXPIRATION DATE: 03-31-20215, (B)(4). BATTERY: (B)(4) - EXPIRATION DATE: 08-31-20215, (B)(4). HEARTWARE HAS OPENED AN INTERNAL INVESTIGATION TO ADDRESS DOUBLE DISCONNECTION FROM BATTERIES TO CONTROLLERS. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 1

    PER THE INSTRUCTIONS FOR USE (IFU): SERIOUS AND LIFE THREATENING ADVERSE EVENTS, INCLUDING DEATH AND THROMBUS HAVE BEEN ASSOCIATED WITH USE OF THIS DEVICE AS OUTLINED IN THE INSTRUCTIONS FOR USE (IFU). THE IFU INDICATES THAT ANTICOAGULATION SHOULD BE INDIVIDUALIZED FOR EACH PATIENT. 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. THE IFU ADDRESSES GUIDELINES FOR OPTIMAL PATIENT MANAGEMENT INCLUDING PRE AND POST-OPERATIVE INCLUDE ARTERIAL AND/OR VENOUS VASCULAR DISEASE, CHRONIC LOW FLOW STATE AND DECREASED MOBILITY. 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. NO FURTHER INFORMATION WILL BE ASKED FOR THIS COMPLAINT AS IT PERTAINS TO THE DT2 STUDY GROUP AND THEY WILL BE RESPONSIBLE FOR THE REPORTABILITY AND FOLLOW UP OF THE EVENT. 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. 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

    IT WAS REPORTED BY THE A US HOSPITAL ENGINEER THAT LOG FILES WERE SENT TO THE MANUFACTURER REQUESTING PUMP OFF TIME AS PATIENT WAS FOUND DOWN AT HOME WITH POWER DISCONNECTED FROM CONTROLLER. PER ENGINEER, AT AROUND 0500 FILES INDICATE THAT "SOMETHING WAS HAPPENING", THEN AT 0600 WIFE WENT INTO ROOM WERE PATIENT WAS AND FOUND PATIENT UNRESPONSIVE. 911 CONTACTED; WHEN EMS ARRIVED, IT WAS NOTED THAT NO POWER WAS GOING TO THE CONTROLLER AND RECONNECTED POWER. PATIENT TAKEN TO ER IN FULL CODE; CHEST COMPRESSIONS ADMINISTERED FOR AN EXTENDED PERIOD OF TIME. PATIENT EXPIRED. SITE IS UNSURE AT THIS TIME IF THE DISCONNECT WAS INTENTIONAL. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. INVESTIGATION IS IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123821 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Death