BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 3930150 · Received July 11, 2014

    Report

    Report Number
    3007042319-2014-00715
    Event Type
    Malfunction
    Date Received
    July 11, 2014
    Date of Event
    March 7, 2014
    Report Date
    June 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

    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. EVALUATION IN PROGRESS.

    Additional Manufacturer Narrative · 1

    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 VIA REVIEW OF THE CONTROLLER LOG FILES, WHICH REVEALED PREMATURE POWER SWITCHING EVENTS. ANALYSIS OF (B)(4) REVEALED THAT THE DEVICES MET SPECIFICATIONS; THE DEVICES PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. ANALYSIS OF (B)(4) REVEALED THAT THE BATTERY FAILED TO MEET SPECIFICATIONS; THE BATTERY FAILED FUNCTIONAL TESTING DUE TO A FAULTY INTERNAL CELL PAIR, WHICH LIKELY CONTRIBUTED TO THE REPORTED EVENT. THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT IS A COMBINATION OF A COMMUNICATION ERROR BETWEEN THE CONTROLLER AND BATTERY AND A FAULTY INTERNAL CELL PAIR RESULTING FROM MULTIFACTORIAL SUPPLIER QUALITY MANUFACTURING ISSUES. HEARTWARE HAS OPENED AN INTERNAL INVESTIGATION TO EVALUATE THESE TYPES OF ISSUES. THERE ARE NO KNOWN CLINICAL OR USER RELATED FACTORS THAT COULD HAVE CONTRIBUTED TO THIS EVENT. AN INTERNAL INVESTIGATION (CAPA) 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 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. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Description of Event or Problem · 1

    APPROXIMATELY FOUR MONTHS POST IMPLANTATION, THE SITE REPORTED THAT THE PATIENT'S CONTROLLER WAS CHANGING POWER SOURCES EARLIER THAN EXPECTED. THE CONTROLLER AND BATTERIES WERE REMOVED FROM THE PATIENT AND A NEW CONTROLLER AND 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
    406753 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| (B)(4) - CONTROLLER| (B)(4) - BATTERY