BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 6125405 · Received November 23, 2016

    Report

    Report Number
    3007042319-2016-04211
    Event Type
    Death
    Date Received
    November 23, 2016
    Date of Event
    November 6, 2016
    Report Date
    November 18, 2016
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HVAD PUMP (B)(4) WAS NOT RETURNED TO MANUFACTURER FOR EVALUATION; TWO CONTROLLERS AND FIVE BATTERIES WERE RECEIVED FOR EVALUATION. REVIEW OF THE MANUFACTURING RECORDS OF PUMP ((B)(4)) REVEALED THAT THE DEVICE MET SPECIFICATIONS PRIOR TO RELEASE. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE RETURNED CONTROLLERS AND BATTERIES IN RELATION TO THE REPORTED EVENT. REVIEW OF THE LOG FILES OF CONTROLLERS ((B)(4)) REVEALED NO ALARMS OR EVENTS LOGGED ON OR NEAR THE REPORTED EVENT DATE OF (B)(6) 2016. THE LAST DATA POINT WAS LOGGED ON CONTROLLER ((B)(4)) AT 12:18:39 AM ON (B)(6) 2016 WITH CAC ADAPTER ON PORT ONE AND BATTERY ((B)(4)) WITH 49% CAPACITY ON PORT TWO. ANALYSIS OF THE TWO CONTROLLERS AND FIVE BATTERIES REVEALED THAT THE DEVICES PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. THERE IS NO EVIDENCE TO SUGGEST THAT A DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE AVAILABLE INFORMATION, THE MOST LIKELY ROOT CAUSE OF THE REPORTED DEATH MAY BE ATTRIBUTED TO DISCONNECTION OF BOTH THE POWER SOURCES FROM THE CONTROLLER. SINCE NO VAD DISCONNECT ALARMS HAVE BEEN LOGGED, THE DRIVELINE WAS LIKELY DISCONNECTED FROM THE CONTROLLER FOLLOWING THE DISCONNECTION OF BOTH THE POWER SOURCES. WHILE THERE IS NO EVIDENCE BASED ON THE AVAILABLE INFORMATION, IT MAY BE POSSIBLE THAT THERE WERE SOME UNDERLYING HEALTH CONDITIONS OR USER-RELATED ISSUES THAT COULD HAVE PREDISPOSED THE PATIENT TO THIS EVENT. FROM ALL INDICATIONS, THE DEVICE OPERATED WITHIN SPECIFICATIONS AND AS INTENDED WITH NO INDICATION OF ANY DEVICE PERFORMANCE ISSUES CONTRIBUTING TO THE EVENT. FURTHERMORE, THE INSTRUCTIONS FOR USE (IFU) AND PATIENT MANUAL, AND TRAINING MATERIAL PROVIDE CLEAR INSTRUCTIONS TO THE USER ON PROPER USAGE AND CARE OF THE DRIVELINE. MOREOVER, THE IFU PROVIDES INSTRUCTION TO FURTHER EDUCATE THE PATIENT ABOUT PRODUCT SAFETY, ALARM MANAGEMENT, AND DEVICE MANAGEMENT; ADDITIONAL GUIDELINES INSTRUCT THE USER ON HOW TO DETECT AND REACT TO A DISCONNECTION OF THE DRIVELINE FROM THE CONTROLLER. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISE WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICES INVOLVED IN THIS EVENT: CONTROLLERS: (B)(4), CATALOG # 1407DE, MFR DATE: 01-31-2016, EXP. DATE: 01-31-2017. (B)(4), CATALOG # 1407DE, MFR DATE: 01-31-2016, EXP. DATE: 01-31-2017. 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. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE PATIENT EXPIRED ON (B)(6) 2016. THE CAUSE OF DEATH WAS NOT PROVIDED AND NO AUTOPSY REPORT WILL BE AVAILABLE. (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

    IT WAS REPORTED THAT THE PATIENT WAS FOUND DEAD AT HOME. BOTH  BATTERIES AND DRIVELINE WERE DISCONNECTED. NO ADDITIONAL INFORMATION WAS PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774912 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC.

    Patients

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