BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 6145920 · Received December 5, 2016

    Report

    Report Number
    3007042319-2016-04304
    Event Type
    Death
    Date Received
    December 5, 2016
    Date of Event
    February 19, 2016
    Report Date
    November 29, 2016
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) WERE NOT RETURNED FOR EVALUATION. REVIEW OF THE DEVICES MANUFACTURING AND INSPECTION RECORDS CONFIRMED THAT THE ASSOCIATED DEVICES MET ALL REQUIREMENTS FOR RELEASE. THE REPORTED EVENT WAS CONFIRMED VIA LOG FILE ANALYSIS WHICH REVEALED CONTROLLER POWER-UP AND MOTOR START EVENT AT 04:54:24 ON (B)(6) 2016 INDICATING THAT BOTH POWER SOURCES HAD BEEN DISCONNECTED FROM THE CONTROLLER. THE LAST DATA POINT RECORDED PRIOR TO THE LOSS OF POWER WAS AT 04:49:49 LEAVING A MAXIMUM PUMP OFF TIME OF APPROXIMATELY FIVE MINUTES. PRIOR TO THE LOSS OF POWER, (B)(4) WAS CONNECTED TO PORT 1 WITH A RSOC OF 97% AND A CAC ADAPTER WAS CONNECTED TO PORT 2. FOLLOWING THE CONTROLLER POWER-UP AND MOTOR START EVENT, THE CONTROLLER HAD A CAC ADAPTER CONNECTED TO PORT 1 AND (B)(4) WITH A RSOC OF 97% CONNECTED TO PORT 2. THREE LOW FLOW ALARMS WERE RECORDED ON (B)(6) 2016 STARTING AT 09:40:48. THERE IS NO EVIDENCE TO SUGGEST THAT A DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE MOST LIKELY ROOT CAUSE OF THE LOSS OF POWER TO THE CONTROLLER IS THE PATIENT DISCONNECTING BOTH POWER SOURCES FROM THE 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 TO INSUFFICIENT OXYGEN AND NUTRIENTS TO THE BODY'S VITAL ORGANS. ALTHOUGH THE CIRCUMSTANCES LEADING TO THE DOUBLE DISCONNECT CANNOT BE CONCLUSIVELY DETERMINED, THE USER'S INTERACTION WITH THE DEVICE ARE LIKELY CONTRIBUTING FACTORS. 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. THOUGH THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE CONCLUSIVELY DETERMINED THERE ARE PATIENT FACTORS THAT ARE LIKELY TO HAVE CONTRIBUTED TO THIS EVENT. OTHER DEVICE INVOLVED IN THIS EVENT: CONTROLLER/(B)(4); (B)(4). HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 1

    OTHER DEVICE INVOLVED IN THIS EVENT: (B)(4). 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. THE HVAD CONTROLLER IS A MICROPROCESSOR UNIT THAT CONTROLS AND MANAGES THE HEARTWARE SYSTEM OPERATION. IT SENDS POWER AND OPERATING SIGNALS TO THE BLOOD PUMP AND COLLECTS INFORMATION FROM THE PUMP. THE HVAD CONTROLLER REQUIRES TWO POWER SOURCES FOR SAFE OPERATION. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), USERS ARE INSTRUCTED TO NEVER DISCONNECT BOTH POWER SOURCES AT THE SAME TIME SINCE THIS WILL STOP THE PUMP. AT LEAST ONE POWER SOURCE MUST BE CONNECTED AT ALL TIMES. USERS ARE ALSO WARNED TO ALWAYS KEEP A SPARE CONTROLLER AND FULLY CHARGED SPARE BATTERIES AVAILABLE AT ALL TIMES IN THE CASE OF AN EMERGENCY. THE IFU EXPLAINS THE CORRECT METHOD OF CONNECTING TO AND DISCONNECTING FROM THE POWER SOURCES AND THE CONTROLLER TO PREVENT DAMAGE TO EITHER THE POWER SOURCE CONNECTIONS OR THE CONTROLLER POWER PORTS. DEATH IS A POTENTIAL EVENT THAT MAY BE ASSOCIATED WITH USE OF THIS PRODUCT. CLINICAL RESULTS AND COMMERCIAL EXPERIENCE DEMONSTRATE THAT THE PLACEMENT OF A VAD IN CHRONIC NYHA CLASS IV PATIENTS IMPROVES SURVIVAL AND QUALITY OF LIFE WHEN COMPARED TO A SIMILAR PATIENT POPULATION RECEIVING CONVENTIONAL THERAPY. BLEEDING AND STROKE ARE KNOWN POTENTIAL COMPLICATIONS ASSOCIATED WITH ALL PATIENTS IMPLANTED WITH VADS AS OUTLINED IN THE INSTRUCTIONS FOR USE (IFU). A USER MUST FULLY CONSIDER THE RISKS OF THIS DEVICE WITH THAT OF OTHER TREATMENT MODALITIES BEFORE DECIDING TO PROCEED WITH DEVICE IMPLANTATION. THE IFU ADDRESSES GUIDELINES FOR OPTIMAL PATIENT MANAGEMENT INCLUDING MEDICAL MANAGEMENT AND THERAPEUTIC ANTICOAGULATION GUIDELINES TO MINIMIZE THE RISKS. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT DISCONNECTED BOTH POWER SOURCES FROM THE CONTROLLER WHILE TRYING TO GET OUT OF BED IN THE MIDDLE OF THE NIGHT AT HOME TO USE THE RESTROOM. THE DISCONNECTION CAUSED THE PUMP TO STOP. THE ASSUMED PUMP STOP TIME WAS LESS THAN ONE MINUTE.  THE PATIENT PASSED OUT AND HIT HER HEAD. THE PATIENT'S HUSBAND WAS NEARBY AND RECONNECTED THE POWER SOURCES IMMEDIATELY. THE PATIENT DEVELOPED CONFUSION AND NAUSEA AND VOMITING SHORTLY AFTER THE FALL. UPON ARRIVAL TO THE EMERGENCY DEPARTMENT (ED), THE PATIENT HAD WAXING/WANING MENTAL STATUS. COMPUTED TOMOGRAPHY (CT) SCAN CONFIRMED TRAUMATIC INTRA-CRANIAL BLEED. THE PATIENT WAS TAKEN TO THE OPERATING ROOM (OR) FOR DECOMPRESSION AND EVACUATION OF HEMATOMA BY NEUROSURGERY.  THE PATIENT WAS GIVEN A VERY POOR PROGNOSIS FOR MEANINGFUL RECOVERY AND HUSBAND ELECTED TO WITHDRAWAL CARE ON THE (B)(6) 2016.  THEREFORE IN ACCORDANCE WITH THE PATIENT'S PREVIOUSLY STATED WISHES, AND THE FAMILY ACTING AS HER ADVOCATE, THE HVAD WAS TURNED OFF, AND VENTILATOR REMOVED, ALLOWING THE PATIENT TO DIE A NATURAL DEATH ON (B)(6) 2016. IT WAS FURTHER STATED THAT BASED ON THE COORDINATOR'S NOTE, IT SOUNDED LIKE THERE WAS AN APPROPRIATE "NO POWER" ALARM. THERE WAS NO "CRITICAL BATTERY" ALARM OR "CONTROLLER FAILED" ALARM. THE SITE DENIED ANY DAMAGE TO THE CONTROLLER OR ANY OF THE PATIENT'S BATTERIES. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795887 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM, PRODUCT CODE, PRODUCT CODE DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death BATTERY/BAT303746| BATTERY/BAT303756