BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP

    MDR report key: 7279677 · Received February 19, 2018

    Report

    Report Number
    3007042319-2018-00661
    Event Type
    Death
    Date Received
    February 19, 2018
    Date of Event
    February 13, 2018
    Report Date
    August 27, 2018
    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
    HEALTH PROFESSIONAL

    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 AND DESTINATION THERAPY 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. OTHER DEVICES ASSOCIATED WITH THIS EVENT: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ CONTROLLER 2.0. MODEL 1420-MCS / EXPIRATION DATE 28FEB2018 / SERIAL NUMBER (B)(4). MFG DATE 28FEB2017. (B)(4) HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ CONTROLLER 2.0. MODEL 1420-MCS / EXPIRATION DATE 28FEB2018 / SERIAL NUMBER (B)(4). MFG DATE 28FEB2017. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY. MODEL 1650DE / EXPIRATION DATE 31JAN2016 / SERIAL NUMBER (B)(4). MFG DATE 31JAN2015. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY. MODEL 1650DE / EXPIRATION DATE 31JAN2016 / SERIAL NUMBER (B)(4). MFG DATE 31JAN2015. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY. MODEL 1650DE / EXPIRATION DATE 31OCT2015 / SERIAL NUMBER (B)(4). MFG DATE 31OCT2014. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY. MODEL 1650DE / EXPIRATION DATE 31OCT2015 / SERIAL NUMBER (B)(4). MFG DATE 31OCT2014. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY. MODEL 1650DE / EXPIRATION DATE 31DEC2016 / SERIAL NUMBER (B)(4). MFG DATE 31DEC2015. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY. MODEL 1650DE / EXPIRATION DATE 31DEC2016 / SERIAL NUMBER (B)(4). MFG DATE 31DEC2015. (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE PUMP, CONTROLLERS AND BATTERIES WERE NOT RETURNED FOR EVALUATION. REVIEW OF THE MANUFACTURING DOCUMENTATION CONFIRMED THAT THE ASSOCIATED DEVICES MET ALL REQUIREMENTS FOR RELEASE. ANALYSIS OF THE CONTROLLER LOG FILES WAS NOT PERFORMED SINCE LOG FILES COVERING THE REPORTED EVENT DATE WERE NOT AVAILABLE FOR ANALYSIS. THE REPORTED EVENT OF NO ALARM SOUNDING COULD NOT BE CONFIRMED. THERE IS NO EVIDENCE TO SUGGEST THAT A DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. GIVEN THAT THE PATIENT WAS DEAD FOR AN UNSPECIFIED PERIOD OF TIME BEFORE BEING FOUND, THE MOST LIKELY ROOT CAUSE OF THE LACK OF A ¿NO POWER¿ ALARM CAN BE ATTRIBUTED TO AN EXTENDED PERIOD OF TIME IN WHICH A CHARGED POWER SOURCE WAS NOT CONNECTED TO THE CONTROLLER. ADDITIONAL PRODUCTS: CONTROLLER 2.0 / (B)(4) MODEL #: 1420 / CATALOG #: 1420 (B)(4). ADDITIONAL PRODUCTS: CONTROLLER 2.0 / (B)(4) MODEL #: 1420 / CATALOG #: 1420 (B)(4); BATTERY / (B)(4)/ MODEL #: 1650DE / CATALOG #: 1650DE(B)(4); BATTERY / (B)(4) MODEL #: 1650DE / CATALOG #: 1650DE (B)(4) BATTERY / (B)(4) MODEL #: 1650DE / CATALOG #: 1650DE (B)(4); BATTERY / (B)(4) MODEL #: 1650DE / CATALOG #: 1650DE (B)(4); BATTERY / (B)(4) MODEL #: 1650DE / CATALOG #: 1650DE (B)(4); BATTERY / (B)(4) MODEL #: 1650DE / CATALOG #: 1650DE (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS FOUND DEAD WITH THE CONTROLLER CONNECTED TO THE DRIVELINE/PUMP AND TO BATTERIES. THE SITE FURTHER REPORTED THAT THEY DID NOT HEAR THE EXPECTED ¿NO POWER ALARM¿. THE PUMP REMAINS IMPLANTED IN THE PATIENT POST-MORTEM.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT HAD BEEN AT A REHABILITATION FACILITY AT THE TIME OF THE EVENT AND THAT THE CAUSE OF DEATH WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123492 HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. 1104

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death