BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 3893531 · Received June 25, 2014

    Report

    Report Number
    3007042319-2014-00652
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    January 15, 2014
    Report Date
    June 2, 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 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 FOUR REPORTS (3007042319-2014-00651, 3007042319-2014-00652, 3007042319-2014-00653, AND 3007042319-2014-00654) 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 AND A CONTROLLER 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 LOG FILES DID NOT REVEAL ANY ABNORMAL EVENTS. THE REPORTED EVENT WAS NOT REPLICATED DURING TESTING; HOWEVER, ANALYSIS OF THE BATTERIES REVEALED THAT FOUR OF THE FIVE BATTERIES ((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. THE CONFIRMED MALFUNCTION IS RELATED TO THE REPORTED EVENT. ANALYSIS OF (B)(4) REVEALED THAT THE DEVICES MET SPECIFICATIONS; THE DEVICES PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT IS A FAULTY INTERNAL CELL PAIR RESULTING FROM MULTIFACTORIAL SUPPLIER QUALITY MANUFACTURING ISSUES. 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 OR USER RELATED FACTORS THAT COULD HAVE CONTRIBUTED TO THIS EVENT. ON APRIL 30, 2014, A FIELD SAFETY NOTICE (FSCA APR2014) WAS ISSUED TO US PHYSICIANS TOGETHER WITH A PATIENT LETTER TO BE DELIVERED BY SITES 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. BOXED INSTRUCTIONS WERE PROVIDED 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. 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. PATIENTS ARE ALSO INSTRUCTED TO KEEP A BACK-UP CONTROLLER AVAILABLE FOR USE. PATIENTS ARE TRAINED ON HOW AND WHEN TO DO A CONTROLLER EXCHANGE SHOULD IT BE NECESSARY. THE INSTRUCTIONS FOR USE AND PATIENT MANUAL INCLUDE A REFERENCE GUIDE FOR ALARMS INCLUDING POTENTIAL CAUSES AND ACTIONS TO TAKE. ADDITIONALLY THERE IS A WARNING TO KEEP SPARE, FULLY CHARGED BATTERIES AND BACK UP CONTROLLER AVAILABLE AT ALL TIME. THE STEPS FOR EXCHANGE OF DEVICES ARE ALSO OUTLINED. 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. 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.

    Description of Event or Problem · 1

    APPROXIMATELY TWO YEARS AND SEVEN MONTHS 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
    372015 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