BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM

    MDR report key: 4200840 · Received October 24, 2014

    Report

    Report Number
    3007042319-2014-01146
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Date of Event
    September 23, 2014
    Report Date
    September 24, 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

    (B)(4). THE RETURNED BATTERY PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING IN A LAB ENVIRONMENT. DURING TESTING, NONE OF THE BATTERY CELL PAIRS EXHIBITED VOLTAGES BELOW THE 2.8 VOLTS LEVEL AND THE FULL CHARGE CAPACITY REMAINED ABOVE 2800 MAH. REVIEW OF THE CONTROLLER LOGS REVEALED THAT THERE WAS A SERIES OF UNTIMELY BATTERY SWITCHING EVENTS POTENTIALLY CAUSED BY A COMMUNICATION ANOMALY BETWEEN THE CONTROLLER AND THE CONNECTED BATTERY. HOWEVER, THIS BATTERY PERFORMED PER SPECIFICATION UNDER TESTING CONDITIONS. (B)(4). THE RETURNED BATTERY PASSED EXTERNAL VISUAL TESTING BUT FAILED FUNCTIONAL TESTING. THE TI GAS GAUGE EVALUATION SOFTWARE SBS SCREEN CAPTURE HAD A PARTIAL TI DISPLAY, INDICATIVE OF A U2 IC CHIP ((B)(4)) IN THE PRINTED CIRCUIT ASSEMBLY (PCA) THAT IS NOT PERFORMING TO SPECIFICATION. (B)(4). THE RETURNED BATTERY PASSED VISUAL AND FUNCTIONAL TESTING. DURING TESTING, NONE OF THE BATTERY CELL PAIRS EXHIBITED VOLTAGES BELOW THE 2.8 VOLT LEVEL AS THE PACK DISCHARGED DOWN TO THE 12 VOLT LEVEL. THIS UNIT WAS ABLE TO COMMUNICATE WITH A TEST-BED SETUP, GIVING NO INDICATION OF A DAMAGED CABLE. LOG FILES ANALYSIS REVEALED THAT THIS BATTERY WAS INVOLVED IN SWITCHING EVENTS PRIOR TO THE 25% THRESHOLD. WHILE THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE CONCLUSIVELY DETERMINED, LOG FILE DATA POINT TOWARD A POTENTIAL COMMUNICATION ANOMALY BETWEEN THE CONTROLLER AND THE CONNECTED BATTERY. INVESTIGATION INTO THIS ISSUE HAS BEEN INITIATED WITH CORRECTIVE ACTIONS/PREVENTIVE ACTIONS IMPLEMENTED BY THE MANUFACTURER. THE PATIENT MANUAL WARNS TO KEEP A SPARE CONTROLLER AND SPARE, FULLY CHARGED BATTERIES AVAILABLE AT ALL TIME AND OUTLINES INSTRUCTIONS FOR EXCHANGE OF DEVICES.

    Additional Manufacturer Narrative · 1

    THE HEARTWARE VAD IS USED FOR TREATMENT NOT DIAGNOSIS. FOUR 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. ANALYSIS OF THE DEVICES REVEALED THREE OF THE BATTERIES ((B)(4)) MET SPECIFICATIONS; THE BATTERIES PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. (B)(4) FAILED TO MEET SPECIFICATIONS; THIS BATTERY FAILED FUNCTIONAL TESTING AS THE BATTERY HAD A FAULTY U2 CHIP. HOWEVER, THIS WAS AN INCIDENTAL FINDING THAT DID NOT CONTRIBUTE TO THE REPORTED SWITCHING EVENTS. THE REPORTED EVENT WAS CONFIRMED VIA REVIEW OF THE CONTROLLER LOG FILES, WHICH REVEALED PREMATURE POWER SWITCHING EVENTS. APPLICABLE RISK DOCUMENTATION AND EXPERIENCE WITH EVENTS OF SIMILAR CIRCUMSTANCES WERE CONSIDERED; EVENTS WITH PREMATURE POWER SWITCHING OF SCREENED BATTERIES ARE MOST OFTEN ATTRIBUTED TO A COMMUNICATION ERROR BETWEEN THE CONTROLLER AND BATTERY. THE MOST LIKELY ROOT CAUSE IS A COMMUNICATION ERROR BETWEEN THE CONTROLLER AND BATTERY. THERE ARE NO KNOWN CLINICAL OR USER RELATED FACTORS THAT COULD HAVE CONTRIBUTED TO THIS EVENT. THE MANUFACTURER HAS OPENED AN INTERNAL INVESTIGATION TO EVALUATE THESE TYPES OF ISSUES. 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. ADDITIONALLY, FSCA APR2015A WAS ISSUED AS A VOLUNTARY "URGENT MEDICAL DEVICE CORRECTION"; COMMUNICATION WAS ISSUED TO THE SITES AND PATIENTS WITHIN THE UNITED STATES ON MAY 11, 2015. AN "URGENT FIELD SAFETY NOTICE" WAS SENT TO SITES AND PATIENTS NOT WITHIN THE UNITED STATES ON MAY 14, 2015. 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. 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.

    Additional Manufacturer Narrative · 1

    THE HVAD REMAINS IMPLANTED IN THE PATIENT, THEREFORE IT WILL NOT BE RETURNED. HOWEVER, THE BATTERIES ((B)(4)) ARE AVAILABLE FOR EVALUATION, BUT HAVE NOT BEEN RECEIVED BY THE MANUFACTURER. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY (30) DAYS OF RECEIPT. PRODUCT REMAINS IMPLANTED.

    Description of Event or Problem · 1

    APPROXIMATELY TEN MONTHS POST HVAD IMPLANTATION, IT WAS REPORTED THAT THE PATIENT EXPERIENCED PREMATURE POWER SWITCHING FROM ONE PORT TO THE OTHER. ALL THE BATTERIES WERE REPLACED AND ARE BEING RETURNED TO HEARTWARE FOR EVALUATION. THERE WAS NO REPORTED PATIENT INJURY AS A RESULT OF THIS EVENT. INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679754 HEARTWARE VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4)_BATTERY| (B)(4)_BATTERY| (B)(4)_BATTERY| (B)(4)_BATTERY