BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 4151072 · Received October 8, 2014

    Report

    Report Number
    3007042319-2014-01043
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    August 28, 2014
    Report Date
    September 11, 2014
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Removal / Correction Number
    Z-1607-2014
    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 BATTERY ((B)(4)) AND CAC ADAPTER ((B)(4)) ARE AVAILABLE FOR EVALUATION, BUT HAVE 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 HEARTWARE VAD IS USED FOR TREATMENT NOT DIAGNOSIS. ONE BATTERY ((B)(4)) AND ONE CAC ADAPTER ((B)(4)) WERE 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. REVIEW OF THE MANUFACTURING DOCUMENTATION CONFIRMED THAT THE ASSOCIATED DEVICES MET ALL REQUIREMENTS FOR RELEASE. THE REPORTED EVENT COULD NOT BE CONFIRMED. THE BATTERY AND CAC ADAPTER PASSED EXTERNAL VISUAL INSPECTION AND FUNCTIONAL TESTING. THE REPORTED EVENT "POWER SWITCHING" WAS NOT CONFIRMED FOR THE CONTROLLER AC ADAPTER. THE COMPLAINT NARRATIVE REFERS TO A "POWER UP" FAILURE THAT WAS VERIFYING VIA CONTROLLER LOG EVENT DATA FILE ANALYSIS. HOWEVER, NO BATTERY RELATED ALARMS WERE LOGGED FOR THE REPORTED EVENT DETAILS. THE BATTERY PERFORMED PER SPECIFICATION. APPLICABLE RISK DOCUMENTATION AND EXPERIENCE WITH EVENTS OF SIMILAR CIRCUMSTANCES WERE CONSIDERED; EVENTS WITH POWER DISCONNECTION OF SCREENED BATTERIES AND CAC ADAPTOR ARE MOST OFTEN ATTRIBUTED TO A COMMUNICATION ERROR AMONG THE CONTROLLER, CAC ADAPTOR, AND BATTERY. THE MOST LIKELY ROOT CAUSE IS A COMMUNICATION ERROR BETWEEN THE CONTROLLER AND BATTERY. THERE ARE NO KNOWN CLINICAL OR USER RELATED FACTORS THAT COULD HAVE CONTRIBUTED TO THIS EVENT. ON APRIL 30, 2014, HEARTWARE ISSUED A FIELD SAFETY NOTICE (FSCA APR2014) AND PATIENT LETTER TO PHYSICIANS; THE SITES DELIVERED THE LETTER 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. INSTRUCTIONS WERE GIVEN 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 AND A BACK-UP CONTROLLER AVAILABLE AT ALL TIMES, BEYOND THE TWO (2) POWER SOURCES THAT ARE CURRENTLY CONNECTED TO THE PRIMARY CONTROLLER. 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.

    Description of Event or Problem · 1

    APPROXIMATELY ONE MONTH POST LVAD IMPLANTATION, IT WAS REPORTED THAT THE PATIENT EXPERIENCED CONTROLLER POWER UP EVENTS. THE BATTERY AND CAC ADAPTER WERE REPLACED AND ARE BEING RETURNED TO HEARTWARE FOR EVALUATION. 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
    633360 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4) - CAC ADAPTER| (B)(4) - BATTERY