BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 3854449 · Received June 6, 2014

    Report

    Report Number
    3007042319-2014-00590
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 7, 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
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE HEARTWARE VAD IS USED FOR TREATMENT NOT DIAGNOSIS. TWO BATTERIES ((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. ANALYSIS OF THE (B)(4) REVEALED THAT THE BATTERY MET SPECIFICATIONS; (B)(4) PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. (B)(4) FAILED FUNCTIONAL TESTING DUE TO A FAULTY INTERNAL CELL PAIR. THE CONFIRMED MALFUNCTION IS RELATED TO THE REPORTED EVENT. ABNORMAL BATTERY BEHAVIOR, E.G. PREMATURE PERFORMANCE DEGRADATION, INTERMITTENT/POOR ELECTRICAL CONNECTION WITH CONTROLLER OR BATTERY CHARGER, PREMATURE POWER SOURCE SWITCHING, ETC., IS A KNOWN ISSUE BEING INVESTIGATED. FSCA APR2014 WAS DISTRIBUTED TO REINFORCE PROPER POWER MANAGEMENT AND WAS EXPANDED WITH FSCA APR2014.1 TO RECALL CERTAIN OLDER BATTERIES. THE MOST LIKELY ROOT CAUSE OF THE POWER SWITCHING IS A FAULTY CELL. THE MANUFACTURER HAS OPENED AN INTERNAL INVESTIGATION TO EVALUATE THESE TYPES OF ISSUES. 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. (B)(4). 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. THIS IS TWO OF TWO REPORTS (3007042319-2014-00589 AND 00590) SUBMITTED FOR DEVICES RELATED TO THE SAME EVENT.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS AVAILABLE FOR EVALUATION, BUT HAS NOT BEEN RECEIVED BY THE MANUFACTURER. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY (30) DAYS OF RECEIPT. THIS IS ONE OF TWO REPORTS (3007042319-2014-00589 AND 3007042319-2014-00590) SUBMITTED FOR DEVICES RELATED TO THE SAME EVENT. NOT YET RECEIVED.

    Description of Event or Problem · 1

    APPROXIMATELY ONE YEAR AND FIVE MONTHS POST HVAD IMPLANTATION, THE SITE REPORTED THAT THE PATIENT BATTERY WAS NOT RECOGNIZED BY THE CONTROLLER. THE BATTERY WAS REMOVED FROM THE PATIENT AND A NEW BATTERY WAS SUPPLIED. NO HARM OR INJURY TO THE PATIENT WAS REPORTED AS A RESULT OF THIS INCIDENT. A PRELIMINARY REVIEW OF THE CONTROLLER LOG FILES REVEALED A LOSS OF POWER ON THE REPORTED EVENT DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332757 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM, BATTERY DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 BAT041049- BATTERY