BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 3842083 · Received May 31, 2014

    Report

    Report Number
    3007042319-2014-00558
    Event Type
    Malfunction
    Date Received
    May 31, 2014
    Date of Event
    October 5, 2013
    Report Date
    May 12, 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 DEVICES HAVE BEEN RECEIVED AND EVALUATION IS STILL ONGOING. PRELIMINARY EVALUATION AND TESTING REVEALED THAT THE RETURNED BATTERY CONTAINED A FAULTY CELL. THIS FINDING WAS RE-ASSESSED PER OUR SOP REQUIREMENTS AND DETERMINED TO BE REPORTABLE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY (30) DAYS OF COMPLETION OF THE INVESTIGATION. THIS IS ONE OF FIVE (3007042319-2014-00557, 00558, 00559, 00560 AND 00561) SUBMITTED FOR DEVICES RELATED TO THE SAME EVENT. EVALUATION IN PROGRESS.

    Additional Manufacturer Narrative · 1

    THE HEARTWARE VAD IS USED FOR TREATMENT NOT DIAGNOSIS. FIVE 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 FOUR DEVICES FAILED TO MEET SPECIFICATIONS. BATTERIES ((B)(4)) FAILED FUNCTIONAL TESTING DUE TO A FAULTY INTERNAL CELL PAIR, WHICH LIKELY CONTRIBUTED TO THE REPORTED EVENT. BATTERY ((B)(4)) HOWEVER PERFORMED AS EXPECTED. 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. THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT IS A FAULTY INTERNAL CELL PAIR RESULTING FROM MULTIFACTORIAL SUPPLIER QUALITY MANUFACTURING ISSUES. AN INTERNAL INVESTIGATION BY MANUFACTURER HAS BEEN OPENED TO ADDRESS THE ISSUE. FOLLOWING ADDITIONAL REGULATORY AUTHORITY FEEDBACK, THE MANUFACTURER HAS EXPANDED THE FIELD SAFETY CORRECTIVE ACTION (FSCA) TO RECALL CERTAIN OLDER BATTERIES (REFERENCED UNDER FILE NAME: FSCA APR2014.1). THE EXPANSION OF THIS FSCA IS TO REMOVE CERTAIN OLDER BATTERIES WHICH WERE PRODUCED IN SPECIFIC RANGES OF BATTERY SERIAL NUMBERS WHICH ARE MORE LIKELY TO EXHIBIT PREMATURE OR UNRECOGNIZED DETERIORATION OF BATTERY CAPACITY. OUR RISK ASSESSMENT FOR THIS ISSUE REMAINS UNCHANGED AT THIS TIME. COMPLAINTS WILL CONTINUE TO BE CLOSELY MONITORED TO ENSURE THAT THE VENTRICULAR ASSIST DEVICE SYSTEM FUNCTIONS AS INTENDED AND TO ASSESS THE EFFECTIVENESS OF THE FSN FOR ADDITIONAL ACTIONS. 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. ANY ADDITIONAL INFORMATION RECEIVED WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT WHEN THE MANUFACTURER'S INVESTIGATION HAS BEEN COMPLETED. 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 FIVE (3007042319-2014-00557, 00558, 00559, 00560 AND 00561) SUBMITTED FOR DEVICES RELATED TO THE SAME EVENT.

    Description of Event or Problem · 1

    APPROXIMATELY FOUR MONTHS POST HVAD IMPLANTATION, THE SITE REPORTED THAT THE PATIENT EXPERIENCED POWER SOURCE CHANGE IN THE CONTROLLER EARLIER THAN EXPECTED. THE BATTERIES WERE REMOVED FROM THE PATIENT AND NEW BATTERIES WERE 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
    320431 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| (B)(4) - BATTERY