BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 3945970 · Received July 21, 2014

    Report

    Report Number
    3007042319-2014-00758
    Event Type
    Malfunction
    Date Received
    July 21, 2014
    Date of Event
    November 6, 2013
    Report Date
    June 20, 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 (3007042319-2014-00756, 3007042319-2014-00757, AND 3007042319-2014-00758) SUBMITTED FOR DEVICES RELATED TO THE SAME EVENT. EVALUATION IN PROGRESS.

    Additional Manufacturer Narrative · 1

    THE HEARTWARE VAD IS USED FOR TREATMENT NOT DIAGNOSIS. A CONTROLLER AND THREE BATTERIES WERE RETURNED FOR EVALUATION. (B)(4) WAS NOT 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 CONFIRMED VIA REVIEW OF THE CONTROLLER LOG FILES, WHICH REVEALED POWER SWITCHING EVENTS. ANALYSIS OF (B)(4) REVEALED THAT THE DEVICES 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 THE CONTROLLER ((B)(4)) REVEALED THAT THE DEVICE MET SPECIFICATIONS; THE CONTROLLER PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. HOWEVER, LOG FILE ANALYSIS REVEALED POWER SWITCHING EVENTS. THE MOST LIKELY ROOT CAUSE OF THE POWER SWITCHING IS A COMBINATION OF BATTERIES WITH FAULTY CELLS AND A COMMUNICATION ERROR BETWEEN THE CONTROLLER AND BATTERIES. 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. THIS IS REPORT TWO OF FOUR REPORTS (3007042319-2014-00756,00757,00758 AND 3007042319-2015-01263) SUBMITTED FOR DEVICES RELATED TO THE SAME EVENT. THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. 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. 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. 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 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.

    Description of Event or Problem · 1

    APPROXIMATELY ELEVEN MONTHS POST HVAD IMPLANTATION, THE SITE REPORTED THAT THE PATIENT HAD 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
    425653 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM, BATTERY DSQ HEARTWARE, INC

    Patients

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