BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM

    MDR report key: 5208226 · Received November 6, 2015

    Report

    Report Number
    3007042319-2015-02788
    Event Type
    Death
    Date Received
    November 6, 2015
    Date of Event
    October 25, 2015
    Report Date
    October 26, 2015
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. PER THE INSTRUCTIONS FOR USE (IFU) AND PATIENT MANUAL: INCLUDE A REFERENCE GUIDE FOR BOTH VISUAL AND TONE ALARMS INCLUDING POTENTIAL CAUSES AND ACTIONS TO TAKE. ALSO STATED, CONTROLLER AND POWER MANAGEMENT AND A QUICK REFERENCE GUIDE FOR ALARMS INCLUDING POTENTIAL CAUSES AND ACTIONS TO TAKE. ADDITIONALLY THERE IS A WARNING TO KEEP SPARE, FULLY CHARGED BATTERIES AND BACK UP CONTROLLER AVAILABLE AT ALL TIME. THE STEPS FOR EXCHANGE OF BATTERIES AND CONTROLLERS ARE OUTLINED. BASED ON THE AVAILABLE INFORMATION A DEFINITIVE CONCLUSION CANNOT BE MADE REGARDING FACTORS POTENTIALLY CONTRIBUTING TO THE REPORTED DEATH. THE SUBMISSION OF THIS REPORT OR RELATED INFORMATION TO THE FDA, AND ITS RELEASE BY FDA, DOES NOT REFLECT A CONCLUSION BY THE PARTY SUBMITTING THIS REPORT OR THE FDA THAT THE REPORT OR RELATED INFORMATION IS AN ADMISSION THAT THE MANUFACTURER, THEIR EMPLOYEES, OR THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION HAS BEEN COMPLETED. THIS IS REPORT ONE OF THREE REPORTS (3007042319-2014-02787, 3007042319-2014-02788, & 3007042319-2014-02789) SUBMITTED FOR DEVICES RELATED TO THE SAME EVENT.

    Additional Manufacturer Narrative · 1

    LOG FILE ANALYSIS: LOG FILE ANALYSIS WAS PERFORMED FOR (B)(4). SIX CONTROLLER POWER-UP AND THREE MOTOR START EVENTS WERE LOGGED ON THE REPORTED EVENT DATE, CONFIRMING THE LOSS OF POWER. THE LAST DATA POINT BEFORE THE FIRST LOSS OF POWER WAS LOGGED 01:28:30 ON (B)(6) 2015, WITH A CONTROLLER AC ADAPTER CONNECTED TO POWER SOURCE PORT 1 AND (B)(4) CONNECTED TO POWER SOURCE PORT 2. A CONTROLLER POWER-UP EVENT OCCURRED 02:38:58 ON (B)(6) 2015 RESULTING IN A TOTAL PUMP OFF TIME BETWEEN 56 AND 70 MINUTES. THE FIRST DATA POINT AFTER THE LOSS POWER SHOWS (B)(4) CONNECTED TO POWER SOURCE PORT 1 AND (B)(4) ON POWER SOURCE PORT 2. TWO LOW FLOW ALARMS WERE LOGGED AFTER THE FIRST LOSS OF POWER AT 03:13:12 AND 03:41:25. POWER SWITCHING EVENTS WERE ALSO NOTED DURING LOG FILE ANALYSIS. THE DEVICE, CONTROLLER, WAS NOT RETURNED FOR EVALUATION. REVIEW OF THE MANUFACTURING DOCUMENTATION CONFIRMED THAT THE ASSOCIATED DEVICE MET ALL REQUIREMENTS FOR RELEASE. THE REPORTED LOSS OF POWER WAS CONFIRMED VIA REVIEW OF CONTROLLER LOG FILES WHICH REVEALED A TOTAL PUMP OFF TIME BETWEEN 56 AND 70 MINUTES. REVIEW OF LOG FILES REVEALED A COMMUNICATION ERROR BETWEEN THE CONTROLLER AND BATTERIES. HOWEVER THIS IS AN INCIDENTAL FINDING AND HEARTWARE HAS OPENED AN INTERNAL INVESTIGATION TO FURTHER EVALUATE THIS ISSUE. THERE IS NO EVIDENCE TO SUGGEST THAT A DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. CLINICALLY, THERE IS THE POSSIBILITY OF PATIENT MISUSE AND AN INTENT TO DISCONNECT HIMSELF FROM THE DEVICE AND IS NOTED BY THE PSYCHOLOGIST AS "SELF-SACRIFICE" AND THE SUSPICION OF THE POLICE AS "USER MISTAKE". WITH REVIEW OF THE REPORTED INFORMATION AND ANALYSIS OF THE RETURNED DEVICE WITH NO CONFIRMED MALFUNCTION, A ROOT CAUSE CANNOT BE DETERMINED. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. THIS IS TWO OF THREE REPORTS (3007042319-2015-02787, 3007042319-2015-02788, & 3007042319-2015-02789) SUBMITTED FOR DEVICES RELATED TO THE SAME EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE REHABILITATION CENTER THAT THE PATIENT WAS FOUND BY THE NIGHT SHIFT NURSE AROUND 2AM, "DEAD IN THE BATHROOM, WITH AN ONGOING SOUND". DURING THE COURSE OF THE NIGHT, THE NIGHT SHIFT NURSE CONFIRMED THAT SHE HAD DISCONNECTED ONE BATTERY FROM THE CONTROLLER WHILE THE OTHER REMAINED CONNECTED, AND THEN CONNECTED THE CAC ADAPTER WHICH WAS WORKING PROPERLY AND WAS CONFIRMED BY THE LOG FILES WHICH SHOWED A CHANGE IN BATTERY TO CAC ADAPTER AT 11:58PM THAT NIGHT. AROUND 2:15AM THE NIGHT SHIFT NURSE NOTICED AN ONGOING SOUND COMING FROM THE PATIENT'S ROOM, ONCE SHE ENTERED SHE ENCOUNTERED THE PATIENT IN THE BATHROOM DEAD. AT THAT TIME THE NURSE STATED THAT THE BATTERIES WERE IN THE WAIST PACK BUT WAS NOT SURE IF THEY WERE CONNECTED, BUT DID RECOGNIZE THE "NO POWER ALARM" GOING OFF. THE RESCUE TEAM WAS THEN CALLED AND THEY FOUND THAT THE PUMP WAS DISCONNECTED TO THE POWER SOURCES, SO THEY RECONNECTED AND RESTARTED THE PUMP AT 2:38AM. THE RESCUE TEAM TRIED TO "REANIMATE PATIENT DUE TO THE LOW FLOW ALARMS AND CIRCULATORY ARREST." IT WAS STATED THAT THE POLICE FOUND BLOOD SPOTS ON THE PATIENT'S BED, ON THE WALLS IN THE DIRECTION OF THE BATHROOM AND IN THE BATHROOM ITSELF. THE BLOODSTAINS WERE ALSO NOTICED AROUND THE PATIENT'S NOSE AND ON BOTH FOREFINGERS. THE THERAPEUTIC TEAM CONFIRMS THAT THE PATIENT WAS A CHRONIC NOSE PICKER WHICH HAD LED TO PREVIOUS BLEEDING ISSUES (EPISTAXIS) AND IT WAS ALSO NOTED THAT PATIENT HAD BEEN ON WARFARIN. THE LOG FILES NOTE LAST DATA POINT LOGGED WAS ON 1:28 AM. IT HAS BEEN STATED THAT THE PATIENT'S DEATH SEEMED TO BE IN THE PROCESS OF "SELF-SACRIFICE" AND THAT THIS WAS CONFIRMED BY THE FOLLOWING: "DAUGHTER, EX WIFE, PSYCHOLOGIST, VAD COORDINATION AND REHAB." IT WAS STATED THAT THE PATIENT WAS "NOT COMPLIANT REGARDING HANDLING OF HIS DEVICE AND THIS WAS ALSO CONFIRMED BY VAD COORDINATOR, WHICH HAD RE-EDUCATED PATIENT SEVERAL TIMES. ON FRIDAY PATIENT GAVE HIS "SIGNATURE FOR ENACTMENT, BUT PSYCHOLOGIST CONFIRMED USAGE OF BOGUS SIGNATURE." SUSPICION BY POLICE IS "USER MISTAKE." THEIR CONCLUSION, ACCORDING TO ALL THE SIGNS IS THAT THE PATIENT HAD A LOSS OF BLOOD FROM HIS NOSE, DISCONNECTED CAC AND WENT TO BATHROOM WITH ONLY ONE BATTERY CONNECTED." "THERE HE RECOGNIZED LOW PRIORITY ALARM AND INSTEAD OF RECONNECTING SECOND BATTERY HE DISCONNECTED SINGLE BATTERY." IT WAS FURTHER STATED THAT "NOBODY IS SUSPECTING DEVICE MALFUNCTION AND THEY WILL NOT APPLY FOR AN AUTOPSY." IT WAS STATED THAT THE SYSTEM WAS TAKEN BY THE POLICE OFFICE. MANUFACTURER REPRESENTATIVE "STARTED THE SYSTEM WITH INVOLVED BATTERIES AND CONTROLLER, AND STATED THAT THE SYSTEM STARTED AS EXPECTED, VAD DISCONNECT ALARM OCCURRED AND THE NO POWER ALARM WAS REPRODUCIBLE AS WELL." ALL BATTERIES WERE FULLY CHARGED, BATTERY CONNECTED TO CONTROLLER HAD 3 BARS OF POWER LEFT. THE POWER PORTS WERE WITHOUT ANY DAMAGES OR BENT PINS, BATTERIES STAYED IN PLACE ON BOTH PORTS, EVEN AS THE POLICE OFFICER PULLED HARD TO DISCONNECT. PATIENT EXPIRED OFFICIALLY AT AROUND 4.30AM. IT WAS STATED THAT DEVICE MALFUNCTION COULD BE EXCLUDED. INVESTIGATION IS ONGOING. NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739283 HEARTWARE VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death