BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 4201099 · Received October 27, 2014

    Report

    Report Number
    3007042319-2014-01122
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    July 11, 2014
    Report Date
    October 10, 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 HEARTWARE VAD IS USED FOR TREATMENT NOT DIAGNOSIS. CONTROLLER ((B)(4)) WAS RETURNED FOR EVALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICES IN RELATION TO THE REPORTED EVENT. THOROUGH EXTERNAL VISUAL INSPECTION OF THE DEVICES REVEALED NO SIGNS OF PHYSICAL DAMAGE OR CONTAMINATION. THE REPORTED EVENT WAS CONFIRMED AS THE CONTROLLER FAILED TO DETECT AC ADAPTER AND BATTERY ON PORT ONE (1). ANALYSIS OF THE DEVICE REVEALED THAT THE DEVICE FAILED TO MEET SPECIFICATIONS. THE CONTROLLER FAILED FUNCTIONAL TESTING DUE TO A SHORTED DIODE WHICH LIKELY CONTRIBUTED TO THE PORT FAILURE. THE CONFIRMED MALFUNCTION IS RELATED TO THE REPORTED EVENT. THERE ARE NO KNOWN CLINICAL FACTORS THAT COULD HAVE CONTRIBUTED TO THIS EVENT. ON APRIL 30, 2014, A FIELD SAFETY NOTICE (FSCA APR2014) WAS ISSUED TO US PHYSICIANS TOGETHER WITH A PATIENT LETTER TO BE DELIVERED BY SITES TO PATIENTS CURRENTLY ON DEVICE. THE FIELD SAFETY NOTICE AND PATIENT LETTER WERE INTENDED TO ENABLE PATIENTS TO RECOGNIZE ABNORMALLY BEHAVING BATTERIES AND TO SPECIFY ACTIONS TO TAKE WHEN A BATTERY NEEDS TO BE REPLACED. THE COMMUNICATIONS OUTLINED GENERAL POWER MANAGEMENT REQUIREMENTS AND FOCUSED ON RECOGNIZING THE ALARMS AND MESSAGE DISPLAYS RELATED TO THE SPECIFIC FAILURE MODES. BOXED INSTRUCTIONS WERE PROVIDED IN THE FIELD SAFETY NOTICE TO PROVIDE ADVICE TO PATIENTS AND SITES ON HOW TO RESPOND IN THE EVENT OF PREMATURE BATTERY SWITCHING, RAPID CAPACITY CHANGE, OR RAPID SWITCHING BACK AND FORTH. ADDITIONALLY, FSCA APR2015A WAS ISSUED AS A VOLUNTARY "URGENT MEDICAL DEVICE CORRECTION"; COMMUNICATION WAS ISSUED TO THE SITES AND PATIENTS WITHIN THE UNITED STATES ON MAY 11, 2015. AN "URGENT FIELD SAFETY NOTICE" WAS SENT TO SITES AND PATIENTS NOT WITHIN THE UNITED STATES ON MAY 14, 2015. 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 SPARE SET OF FULLY CHARGED BATTERIES AVAILABLE AT ALL TIMES, BEYOND THE TWO (2) POWER SOURCES THAT ARE CURRENTLY CONNECTED TO THE CONTROLLER. 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.

    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 BY THE MANUFACTURER FOR FURTHER EVALUATION. ADDITIONAL INFORMATION WILL BE SUBMITTED WITH-IN THIRTY (30) DAYS OF COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    APPROXIMATELY SEVEN DAYS POST HEARTWARE LVAD IMPLANTATION, THE SITE REPORTED THAT THE PATIENT UNDERWENT AN ELECTIVE CONTROLLER EXCHANGE DUE TO THE CONTROLLER NOT RECOGNIZING POWER ON ONE PORT OR DATA CONNECTIONS. 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
    681367 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

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