BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 4822029 · Received June 5, 2015

    Report

    Report Number
    3007042319-2015-01118
    Event Type
    Malfunction
    Date Received
    June 5, 2015
    Date of Event
    January 1, 2015
    Report Date
    June 4, 2015
    Manufacturer
    HEARTWARE
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Removal / Correction Number
    Z-1607-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HEARTWARE VAD IS USED FOR TREATMENT NOT DIAGNOSIS. THE CONTROLLER WAS EXCHANGED BUT NOT RETURNED DESPITE MULTIPLE ATTEMPTS TO OBTAIN IT. THE BATTERIES WERE RETURNED TO HEARTWARE FOR EVALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICES IN RELATION TO THE REPORTED EVENT. LOG FILE ANALYSIS REVEALED TWO CONTROLLER POWER UP AND MOTOR START EVENTS WERE LOGGED SINCE (B)(6) 2014 INDICATING THAT BOTH POWER SOURCES WERE DISCONNECTED. ANALYSIS OF THE DEVICES REVEALED THAT THE DEVICES FAILED TO MEET SPECIFICATIONS; ALL THE BATTERIES PASSED VISUAL EXAMINATION BUT FAILED FUNCTIONAL TESTING DUE TO A FAULTY INTERNAL CELL PAIR, WHICH LIKELY CONTRIBUTED 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. THE ROOT CAUSE OF THE REPORTED EVENT IS MOST LIKELY A FAULTY INTERNAL CELL PAIR. 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. 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. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. THIS IS ONE OF 5 REPORTS (3007042319-2014-00330, 3007042319-2015-01116, 3007042319-2015-01117, 3007042319-2015-01118 AND 3007042319-2015-01119) SUBMITTED FOR DEVICES RELATED TO THE SAME EVENT.

    Description of Event or Problem · 1

    APPROXIMATELY TWO YEARS AND EIGHT MONTHS POST IMPLANTATION, IT WAS REPORTED THAT THE CONTROLLER DISPLAY TURNED OFF FOR A FEW SECONDS, THEN TURNED BACK ON NORMALLY. AN ALARM WAS ACTIVATED AND DEACTIVATED IMMEDIATELY AFTER. THERE WAS NO REPORTED PATIENT INJURY AS A RESULT OF THE EVENT. THE CONTROLLER WAS EXCHANGED BY THE PHYSICIAN BUT NOT RETURNED DESPITE MULTIPLE ATTEMPTS TO OBTAIN IT. THE BATTERIES WERE REPLACED AND RETURNED TO HEARTWARE FOR EVALUATION. ADDITIONAL INFORMATION RECEIVED REVEALED A LOSS OF POWER TO THE CONTROLLER ON THE REPORTED EVENT DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363734 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE

    Patients

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