BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 6188965 · Received December 20, 2016

    Report

    Report Number
    3007042319-2016-04468
    Event Type
    Death
    Date Received
    December 20, 2016
    Date of Event
    December 13, 2016
    Report Date
    December 14, 2016
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 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. DEATH IS A POTENTIAL EVENT THAT MAY BE ASSOCIATED WITH USE OF THE 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. FURTHERMORE, THESE BENEFITS APPLY TO PATIENTS BEING BRIDGED TO HEART TRANSPLANT, PATIENTS RECEIVING PERMANENT SUPPORT (DESTINATION THERAPY), AND THOSE BEING SUPPORTED WITH THE EXPECTATION FOR MYOCARDIAL RECOVERY. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. PRODUCT HAS BEEN NOT RETURNED.

    Additional Manufacturer Narrative · 1

    IT WAS FURTHER STATED THAT ACCORDING TO THE LOG FILES, THE PATIENT WAS CONNECTED TO A BATTERY AND AC POWER WHEN THE DOUBLE DISCONNECT OCCURRED. THERE WAS EVIDENCE THAT PATIENT FACTORS WERE A ROLE IN THE DOUBLE DISCONNECT AS THE PATIENT WAS WELL TRAINED AND INDEPENDENT ON THE DEVICE. THE SUPPORT WAS DISCONTINUED ON (B)(6) 2016 AND THE PATIENT EXPIRED THE SAME DAY. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT OF A DOUBLE DISCONNECTION WAS CONFIRMED ON THE RETURNED CONTROLLER, (B)(4). VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICE IN RELATION TO THE REPORTED EVENT. LOG FILE ANALYSIS REVEALED A CONTROLLER POWER-UP ON (B)(6) 2016 AT 22:13:54. THE LAST DATA ENTRY PRIOR TO THE CONTROLLER POWER UP WAS LOGGED AT 21:39:15, WHICH RECORDED A CONTROLLER AC ADAPTER CONNECTED TO POWER PORT 1 AND (B)(4) CONNECTED TO POWER PORT 2 WITH 77% RELATIVE STATE OF CHARGE (RSOC). THE DATA POINT RECORDED IN THE DATA FILE, AFTER THE CONTROLLER POWER UP, WAS LOGGED AT 22:28:52 AND REVEALED THAT (B)(4) WAS CONNECTED TO POWER PORT 1 WITH 71% RSOC AND (B)(4) WAS CONNECTED TO POWER PORT 2 WITH 77% RSOC. THE MAXIMUM PUMP OFF TIME IS 35 MINUTES. TWO LOW FLOW ALARMS WERE RECORDED AFTER THE REPORTED EVENT, AT 22:14:09 AND 22:14:31. ANALYSIS REVEALED THAT THE DEVICE PASSED VISUAL EXAMINATION AND FUNCTIONAL TESTING. THE CONTROLLER WAS PERMITTED TO RUN FOR OVER TWO HOURS AT AMBIENT TEMPERATURE TO VERIFY THAT THE "NO POWER" ALARM WAS FUNCTIONAL. RESULTS REVEALED THAT THE "NO POWER" AUDIBLE ALARM SOUNDED PROPERLY WHEN A DOUBLE DISCONNECTION OF BOTH EXTERNAL POWER SOURCES WAS TESTED. BASED ON THE AVAILABLE INFORMATION, THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO A DISCONNECTION OF BOTH POWER SOURCES. THERE WAS EVIDENCE THAT PATIENT FACTORS WERE A ROLE IN THE DOUBLE DISCONNECT AS THE PATIENT WAS WELL TRAINED AND INDEPENDENT ON THE DEVICE. 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 NOTED BY THE SITE THAT THIS PATIENT WAS FOUND UNRESPONSIVE IN HER HOSPITAL BED DURING THE NIGHT WITH BOTH POWER SOURCES DISCONNECTED FROM HER CONTROLLER. THERE WAS NO 'NO POWER ALARM NOTED' BY THE STAFF. POWER WAS RECONNECTED BY THE NURSE BUT PATIENT REMAINED UNRESPONSIVE. THE PATIENT WAS INTUBATED AND MOVED TO THE ICU FROM THE STEP-DOWN UNIT. ON THE EVENING OF (B)(6) 2016, PATIENT REMAINED UNRESPONSIVE WITH NO REACTION TO PAIN. WHEN THE LOGFILES WERE ANALYZED, IT WAS NOTED THAT THE CONTROLLER REMAINED WITHOUT POWER FROM ANYWHERE AROUND 20 MIN TO 35 MIN. ENGINEERS SWITCHED PATIENT TO A NEW CONTROLLER TO ASSES THE ONE THAT SHE WAS FOUND DISCONNECTED ON. WHEN TESTED IN THE LAB BY PERFORMING A DOUBLE POWER DISCONNECT, THE 'NO POWER' ALARM SOUNDED APPROPRIATELY FOR A FEW MINUTES BEFORE THE TEAM SHUT IT OFF. SUPPORT OF THE PATIENT WAS DISCONTINUED ON (B)(6) AS IT DID NOT APPEAR PATIENT WOULD RECOVER FROM THIS EVENT. PATIENT WAS ALSO SUFFERING FROM CANCER AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839714 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM, BATTERY DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death