BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 4233077 · Received November 6, 2014

    Report

    Report Number
    3007042319-2014-01210
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 20, 2014
    Report Date
    October 20, 2014
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HVAD IS USED FOR TREATMENT NOT DIAGNOSIS. IT WAS REPORTED THAT THE 39 YEAR FEMALE PATIENT' CONTROLLER DISPLAY SCREEN WAS FADED. THE DEVICE WAS REMOVED FROM SERVICE AND THE PATIENT WAS ISSUED A REPLACEMENT DEVICE. THERE WAS NO REPORTED PATIENT INJURY AS A RESULT OF THIS EVENT. THE CONTROLLER ((B)(4)) WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEW IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICES IN RELATION TO THE REPORTED EVENT. THE CONTROLLER FAILED FUNCTIONAL TESTING AS A RESULT OF MISSING PIXELS ON THE DISPLAY SCREEN. SUPPLEMENTAL INVESTIGATION REVEALED THAT THE DISPLAY CONNECTOR CABLE ASSEMBLY WAS NOT PROPERLY CONNECTED LEADING TO A REPLICABLE DISPLAY ERROR EVEN WITH A FUNCTIONING DISPLAY SCREEN. THE ROOT CAUSE FOR THE REPORTED "DISPLAY ERROR" CAN BE ATTRIBUTED TO A DISPLAY CONNECTION FAILURE. 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. 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. (B)(4) - CONTROLLER.

    Additional Manufacturer Narrative · 1

    THE SITE HAS INDICATED THAT THE PUMP REMAINS IMPLANTED AND THAT THE CONTROLLER HAS BEEN RECEIVED AND IS AWAITING FURTHER ANALYSIS. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    APPROXIMATELY ELEVEN MONTHS AND TWO WEEKS POST HEARTWARE VAD IMPLANTATION, IT WAS REPORTED THAT THE PATIENT UNDERWENT A CONTROLLER EXCHANGE DUE TO A FAULTY CONTROLLER DISPLAY. THERE WAS NO REPORTED PATIENT INJURY AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715984 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention