BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM

    MDR report key: 6041559 · Received October 19, 2016

    Report

    Report Number
    3007042319-2016-03702
    Event Type
    Death
    Date Received
    October 19, 2016
    Date of Event
    October 5, 2016
    Report Date
    October 6, 2016
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 IMPLANTATION OF A VAD IS AN INVASIVE PROCEDURE REQUIRING GENERAL ANESTHESIA, MEDIAN STERNOTOMY, A VENTILATOR AND CARDIOPULMONARY BYPASS. A USER MUST FULLY CONSIDER THE RISKS OF THIS DEVICE WITH THAT OF OTHER TREATMENT MODALITIES BEFORE DECIDING TO PROCEED WITH DEVICE IMPLANTATION. THESE SURGICAL PROCEDURES ARE ASSOCIATED WITH NUMEROUS RISKS. DEATH IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE IMPLANTATION OF ALL VADS AS OUTLINED IN THE INSTRUCTIONS FOR USE. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. PRODUCT NOT RETURNED.

    Additional Manufacturer Narrative · 1

    TWO CONTROLLERS, SIX BATTERIES, TWO CAC ADAPTERS, AND A BATTERY CHARGER WERE RETURNED FOR EVALUATION. THE PUMP WAS NOT RETURNED FOR EVALUATION. REVIEW OF THE MANUFACTURING RECORDS CONFIRMED THAT (B)(4) MET ALL REQUIREMENTS PRIOR TO RELEASE. LOG FILE ANALYSIS REVEALED THAT THE LAST DATA POINT RECORDED WAS ON (B)(6) 2016 AT 08:50:22. THE LAST DATA POINT INDICATED THAT THE CONTROLLER WAS OPERATING ON (B)(4) WITH 64% RSOC ON POWER SOURCE PORT 1 AND NO POWER SOURCE CONNECTED TO POWER SOURCE PORT 2. IN ADDITION, THE LOG FILES INDICATED THE CONTROLLER HAD BEEN OPERATING ON A SINGLE BATTERY FOR THE PREVIOUS 60 MINUTES. NO ALARMS OR EVENTS WERE RECORDED ON THE REPORTED EVENT DATE. ANALYSIS OF THE SIX BATTERIES, TWO CAC ADAPTERS, BATTERY CHARGER, AND (B)(4) REVEALED THAT THE DEVICES MET SPECIFICATIONS; THE DEVICES PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. ANALYSIS OF (B)(4) REVEALED THAT THE CONTROLLER PASSED VISUAL INSPECTION BUT FUNCTIONAL TESTING REVEALED THAT THE "NO POWER" ALARM FAILED TO SOUND WHEN BOTH POWER SOURCES WERE DISCONNECTED. EVALUATION OF THE INTERNAL NICKEL-METAL HYDRIDE (NIMH) BATTERY REVEALED A FAULTY CELL ON THE INTERNAL BATTERY. AS A RESULT, THE MOST LIKELY ROOT CAUSE OF THE CONTROLLER FAILING TO SOUND THE "NO POWER" ALARM CAN BE ATTRIBUTED TO A FAULTY INTERNAL NIMH BATTERY. HEARTWARE HAS OPENED AN INVESTIGATION TO EVALUATE "NO POWER" AUDIBLE ALARM FAILURES. THE MOST LIKELY ROOT CAUSE OF THE PATIENT LOSING POWER CAN BE ATTRIBUTED TO THE DISCONNECTION OF BOTH POWER SOURCES FROM THE CONTROLLER. THE MOST LIKELY ROOT CAUSE OF THE CONTROLLER FAILING TO SOUND THE "NO POWER" ALARM CAN BE ATTRIBUTED TO A FAULTY INTERNAL NIMH BATTERY. HEARTWARE HAS OPENED AN INVESTIGATION TO EVALUATE "NO POWER" AUDIBLE ALARM FAILURES. THE MOST LIKELY ROOT CAUSE OF THE PATIENT LOSING POWER CAN BE ATTRIBUTED TO THE DISCONNECTION OF BOTH POWER SOURCES FROM THE CONTROLLER. THERE IS NO EVIDENCE TO SUGGEST THAT THE DEVICE MALFUNCTION OF THE CONTROLLER INTERNAL BATTERY WOULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE INTERNAL BATTERY ONLY POWERS THE ALARM AND WOULD NOT CAUSE THE CONTROLLER TO TURN OFF. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED FROM THE SITE. 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 FROM THE SITE THAT THE PATIENT WAS FOUND DECEASED AT HOME YESTERDAY ((B)(6)) BY HIS WIFE. IT WAS STATED THAT THE AUTOPSY IS PENDING COMPLETION, AS THE CORONER IS AWAITING THE FULL INVESTIGATION OF THE EQUIPMENT TO DETERMINE CAUSE OF DEATH ON DEATH CERTIFICATE. EQUIPMENT WAS STATED WOULD BE SENT TO MANUFACTURER UPON RECEIPT. IT WAS FURTHER STATED THAT THE DEATH WAS THOUGHT TO BE "SUSPICIOUS." NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692330 HEARTWARE VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM, BATTERY DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Death BATTERY - (B)(4)| CONTROLLER - (B)(4)