BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 3870556 · Received June 12, 2014

    Report

    Report Number
    3007042319-2014-00612
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    December 31, 2013
    Report Date
    May 15, 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
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED AND EVALUATION IS ONGOING. PRELIMINARY EVALUATION AND TESTING REVEALED THAT THE RETURNED BATTERY CONTAINED A FAULTY CELL. THIS FINDING WAS RE-ASSESSED PER SOP REQUIREMENTS, AND DETERMINED TO BE REPORTABLE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY (30) DAYS OF RECEIPT. THIS IS ONE OF THREE REPORTS (3007042319-2014-00612 3007042319-2014-00613, AND 3007042319-2014-00614) SUBMITTED FOR DEVICES RELATED TO THE SAME EVENT. EVALUATION IN PROGRESS.

    Additional Manufacturer Narrative · 1

    THE HEARTWARE VAD IS USED FOR TREATMENT NOT DIAGNOSIS. FOUR BATTERIES 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. THE REPORTED EVENT WAS NOT REPLICATED DURING TESTING; HOWEVER, ANALYSIS OF THE BATTERIES REVEALED THAT THE DEVICES ((B)(4)) FAILED TO MEET SPECIFICATIONS. THESE BATTERIES FAILED FUNCTIONAL TESTING DUE TO A FAULTY INTERNAL CELL PAIR, WHICH LIKELY CONTRIBUTED TO THE REPORTED EVENT. BATTERY ((B)(4)) PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. 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. THERE ARE NO KNOWN CLINICAL 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. HEARTWARE LATER EXPANDED THE VOLUNTARY FIELD ACTION, FSCA APR2014.1, FOR THE REMOVAL OF UNSCREENED BATTERIES ((B)(4)) FROM THE FIELD. 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. THIS IS ONE OF THREE REPORTS (3007042319-2014-00612, 2014-00613 AND 00614) SUBMITTED FOR DEVICES RELATED TO THE SAME EVENT. (B)(4).

    Description of Event or Problem · 1

    APPROXIMATELY ONE YEAR POST HVAD IMPLANTATION, THE SITE REPORTED THAT THE PATIENT EXPERIENCED A POWER SOURCE CHANGE IN THE CONTROLLER EARLIER THAN EXPECTED. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348494 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM, BATTERY DSQ HEARTWARE, INC

    Patients

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