BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM

    MDR report key: 6082002 · Received November 7, 2016

    Report

    Report Number
    3007042319-2016-03986
    Event Type
    Death
    Date Received
    November 7, 2016
    Date of Event
    October 22, 2016
    Report Date
    October 24, 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

    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 SYSTEM. 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. THE INSTRUCTIONS FOR USE (IFU) AND PATIENT MANUAL EXPLAIN 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. ACCORDING TO THE IFU AND PATIENT MANUAL, USERS ARE INSTRUCTED TO RETURN ANY DAMAGED COMPONENTS TO HEARTWARE. IF THE CONTROLLER IS ONLY CONNECTED TO ONE POWER SOURCE, THE CONTROLLER WILL FUNCTION, BUT WILL SOUND AN ALARM AFTER TWENTY SECONDS. IN ADDITION, THE USER IS CAUTIONED TO ALWAYS HAVE ADDITIONAL BATTERIES AVAILABLE AND TO HAVE A BACKUP CONTROLLER AVAILABLE AND PROGRAMMED IDENTICALLY TO THE PRIMARY CONTROLLER. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. DEVICE NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    THE CONTROLLER, CON094603, 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. REVIEW OF THE MANUFACTURING DOCUMENTATION CONFIRMED THAT THE ASSOCIATED DEVICE MET ALL REQUIREMENTS FOR RELEASE. LOG FILE ANALYSIS REVEALED THAT NO ALARMS OR CONTROLLER POWER UP AN MOTOR START EVENTS WERE RECORDED ON THE EVENT DATE OF (B)(6) 2016. THE LAST DATA POINT THAT WAS RECORDED WAS ON (B)(6) 2016 AT 11:47:08. BATTERY BAT314676 WAS CONNECTED TO POWER PORT 1 WITH 26% RELATIVE STATE OF CHARGE (RSOC); BAT314676 WAS THE ACTIVE POWER SOURCE. BATTERY BAT300835 WAS CONNECTED TO POWER PORT 2 WITH 88% RSOC. NO ABNORMALITIES WERE NOTED IN THE LOG FILES LEADING UP TO THE LAST DATA POINT. LOG FILE ANALYSIS SUGGEST THAT THE PATIENT WAS MOST LIKELY GOING TO EXCHANGE BAT314676, WITH 26% RSOC, ON POWER PORT 1 WITH A FULLY CHARGED BATTERY. ANALYSIS OF THE CONTROLLER REVEALED THAT THE UNIT FAILED FUNCTIONAL TESTING DUE TO A FAILURE OF THE "NO POWER" ALARM WHEN BOTH POWER SOURCES WERE DISCONNECTED. AN INTERNAL EVALUATION OF THE CONTROLLER REVEALED THAT THE INTERNAL NICKEL-METAL HYDRIDE BATTERY (NIMH) BATTERY THAT PROVIDES POWER FOR THE "NO POWER" ALARM WAS FOUND FAULTY. THE CELL VOLTAGES OF THE INTERNAL BATTERY WERE FOUND BELOW THE EXPECTED VOLTAGE AFTER CHARGING THE BATTERY. ADDITIONALLY, THE BATTERY WAS FOUND WITH SIGNS OF LEAKAGE. THE MANUFACTURER HAS OPENED AN INTERNAL INVESTIGATION TO DETERMINED THAT THE FAILURE OF THE "NO POWER" AUDIBLE ALARM MAY BE DUE TO CRACKED BATTERY CELLS AND AN INADEQUATE WELDING PROCESS. ANALYSIS OF BAT300835 AND BAT314676 REVEALED THAT THE UNITS MET SPECIFICATIONS; THE BATTERIES PASSED VISUAL AND FUNCTIONAL TESTING. THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO A DISCONNECTION OF BOTH POWER SOURCES, LIKELY WHEN THE PATIENT WAS ABOUT TO EXCHANGE A LOW CAPACITY BATTERY FOR A FULLY CHARGED UNIT. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 1

    HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION RECEIVED VIA VOLUNTARY MEDWATCH (REPORT # (B)(4)) INDICATES THAT THE PATIENT'S SON WAS AT THE SCENE AFTER HIS FATHER HAD BEEN FOUND. HE WAS ABLE TO DISCONNECT THE PATIENT'S DRIVELINE WITHOUT DIFFICULTY AND THE PATIENT'S CONTROLLER GIVEN TO THE SHERIFF'S OFFICE. THIS INFORMATION ALSO INCLUDED A REPORTED TIMELINE OF EVENTS PRIOR TO THE PATIENT'S DEATH. ON (B)(6) 2016, THE PATIENT IS REPORTED TO HAVE COMPLAINED OF A BUG BITE THAT WAS BOTHERING HIM TO HIS FAMILY. ON (B)(6) 2016 AT 1400HRS, THE PATIENT WAS APPARENTLY NOT FEELING WELL AND WENT TO TAKE A NAP. THOUGH HE LIVES ALONE, THE PATIENT'S SISTER AND HER HUSBAND WERE STAYING ON HIS PROPERTY IN A MOTOR HOME. THE PATIENT HAD ASKED HIS SISTER TO WAKE HIM UP AT 1500HRS SINCE THEY HAD PLANS FOR THE AFTERNOON. AT 1445HRS, THE PATIENT'S SISTER WENT INTO THE HOME AND FOUND THE PATIENT STILL IN BED. AT 1500HRS, THE PATIENT'S BROTHER-IN-LAW IS REPORTED TO HAVE GONE INTO THE HOUSE AND FOUND THE PATIENT DEAD IN THE HALLWAY FACE DOWN WITH "BLOOD EVERYWHERE." THE PATIENT'S BROTHER-IN-LAW REPORTED THAT THERE WERE NO HVAD ALARMS AT THAT TIME. THE FAMILY REPORTED THAT IT LOOKED LIKE THE PATIENT WAS HEADING TOWARD THE BATTERY CHARGER. THE PATIENT WAS FOUND WITH NO POWER SOURCES ATTACHED TO HIS CONTROLLER; WITH ONE BATTERY WITH ONE YELLOW BAR UNDER HIM AND A SECOND FULLY CHARGED BATTERY NEARBY. IT APPEARS THAT THE SHERIFF'S DEPARTMENT WAS CONCLUDED THAT THERE WAS NO FOUL PLAY SUSPECTED AND RELEASE THE CONTROLLER TO A LOCAL PHYSICIAN'S ASSISTANT WHO WILL BE SENDING IT TO THE HOSPITAL FOR INTERROGATION. (B)(4) 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

    A REPORT WAS RECEIVED THAT A PATIENT WAS FOUND FACE DOWN ON THE FLOOR AT HOME. THE SITE REPORTED THAT IT APPEARED THAT HE HAD ACCIDENTALLY DISCONNECTED BOTH OF HIS BATTERIES AND HAD FALLEN. THEY FURTHER REPORTED THAT THE PATIENT'S DRIVELINE WAS STILL CONNECTED AT THE TIME. THE PATIENT IS KNOWN TO LIVE ALONE IN RURAL (B)(6) AND IS A FARMER. HE HAS HAD MULTIPLE ISSUES WITH PREVIOUS CONTROLLERS WITH BENT PINS AND GETTING DEBRIS IN HIS CONTROLLERS. HE IS ALSO KNOWN TO BE COMFORTABLE WITH CHANGING HIS OWN CONTROLLER WITHOUT ASSISTANCE. THE PATIENT'S FAMILY DECLINED AN AUTOPSY AND THE PUMP WILL NOT BE RETRIEVED POST-MORTEM. ONCE THE CONTROLLER IS RELEASED BACK TO THE SITE FROM THE SHERIFF'S DEPARTMENT, THEY PLAN TO RETURN IT TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733896 HEARTWARE VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM, CONTROLLER DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death