BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 4181894 · Received October 17, 2014

    Report

    Report Number
    3007042319-2014-01097
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 16, 2014
    Report Date
    September 17, 2014
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HVAD IS USED FOR TREATMENT NOT DIAGNOSIS. IT WAS REPORTED THAT PATIENT HAD A BLANK DISPLAY ON THE CONTROLLER DURING A VISIT TO THE SITE. THERE WERE NO ALARMS NOTED AND THE CONTROLLER WAS EXCHANGED BY THE SITE, USING THE PATIENT'S BACKUP CONTROLLER. THERE WAS NO REPORTED PATIENT INJURY AS A RESULT OF THIS EVENT. THE CONTROLLER, (B)(4), WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE CONTROLLER PASSED VISUAL INSPECTION AND FUNCTIONAL TEST AND RAN WITHOUT ANY ALARMS. THERE IS NO EVIDENCE OF THE DISPLAY GOING BLANK. THERE WAS NO MALFUNCTION FOUND DURING TESTING. REVIEW OF THE LOG FILES WHICH REVEALED SEVERAL CONTROLLER AND MOTOR STARTS LEADING UP TO THE EVENT DATE. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AS THE DEVICE FUNCTIONED PER SPECIFICATION, HOWEVER IT IS POSSIBLE THAT USER ERROR/PERCEPTION MAY HAVE ATTRIBUTED TO THE REPORTED EVENT. 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. PER THE INSTRUCTIONS FOR USE (IFU): PATIENTS ARE INSTRUCTED TO ALWAYS KEEP A BACK-UP CONTROLLER AVAILABLE AT ALL TIMES, BEYOND THE PRIMARY CONTROLLER THAT IS CURRENTLY IN USE. PATIENTS ARE INSTRUCTED TO CONTACT THE TREATING FACILITY IF THEY RECEIVE ANY OF A LIST OF CERTAIN ALARMS. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. 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. CONTROLLER - (B)(4)/1403 US - EXPIRATION DATE. 08/31/2014. (B)(4).

    Additional Manufacturer Narrative · 1

    THE HVAD REMAINS IMPLANTED IN THE PATIENT, THEREFORE, IT WILL NOT BE RETURNED. HOWEVER, THE CONTROLLER ((B)(4)) HAS BEEN RECEIVED AND IS AWAITING FURTHER ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY (30) DAYS OF RECEIPT. PRODUCT REMAINS IMPLANTED.

    Description of Event or Problem · 1

    APPROXIMATELY THREE MONTHS AND TWO WEEKS POST HEARTWARE LVAD IMPLANTATION, IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE SITE AND UNDERWENT AN ELECTIVE CONTROLLER EXCHANGE DUE TO A FAULTY CONTROLLER DISPLAY NOTICED THE DAY PRIOR. 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
    660849 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1