BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 4170049 · Received October 14, 2014

    Report

    Report Number
    3007042319-2014-01053
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    September 16, 2014
    Report Date
    September 16, 2014
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HVAD REMAINS IMPLANTED IN THE PATIENT, THEREFORE IT WILL NOT BE RETURNED. HOWEVER, THE CONTROLLER ((B)(4)) IS AVAILABLE FOR EVALUATION, BUT HAS NOT BEEN RECEIVED BY THE MANUFACTURER. ADDITIONAL INFORMATION WILL BE SUBMITTED WITH-IN THIRTY (30) DAYS OF COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    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, INCLUDING TRANSPORTATION. THREE (3) ATTEMPTS HAVE BEEN MADE TO REQUEST THE RETURN OF THE CONTROLLER HOWEVER IT HAS NOT BEEN RECEIVED. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS DESPITE MULTIPLE ATTEMPTS TO OBTAIN IT. A CONTROLLER POWER UP AND MOTOR START WAS LOGGED ON (B)(4) SHOWING DATE OF (B)(4) 2014 INDICATING THAT BOTH POWER SOURCES WERE DISCONNECTED; DUE TO ISSUES WITH INTERNAL CONTROLLER CLOCK, WE ARE UNABLE TO IDENTIFY THE CORRECT TIME OF THE EVENT. A POTENTIAL ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED DUE TO THE DEVICE NOT BEING RETURNED FOR EVALUATION. HEARTWARE IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER FLA-14-14, DATED JUNE 2, 2014, AND PURSUANT TO THE PROVISIONS OF 21 CFR PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HEARTWARE HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. THE DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, HEARTWARE, OR ITS EMPLOYEES THAT THIS REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, HEARTWARE, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    THE PATIENT DID NOT REPORT ANY SIGNS OF HEMODYNAMIC INSTABILITY BEFORE, DURING OR AFTER THE "POWER-UP" EVENT. PRELIMINARY ANALYSIS OF THE LOG FILES SHOWED A POWER-UP AND MOTOR START INDICATING THAT BOTH POWER SOURCES WERE DISCONNECTED. THE CORRECT TIME OF THE EVENT WAS NOT ABLE TO BE DETERMINED DUE TO ISSUES WITH THE INTERNAL CONTROLLER CLOCK.

    Description of Event or Problem · 1

    APPROXIMATELY ELEVEN MONTHS AND THREE WEEKS POST HEARTWARE HVAD IMPLANTATION, IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ELECTIVE CONTROLLER EXCHANGE AFTER EXPERIENCING A CONTROLLER 'POWER-UP MOTOR START' EVENT. THERE WAS NO REPORTED PATIENT INJURY AS A RESULT OF THIS EVENT. INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650894 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

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