BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 4171595 · Received October 14, 2014

    Report

    Report Number
    3007042319-2014-01104
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    May 26, 2014
    Report Date
    September 18, 2014
    Manufacturer
    HEARTWARE
    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
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRELIMINARY EVALUATION AND TESTING REVEALED THAT THE RETURNED BATTERY (B)(4) 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. PRODUCT REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    THE HEARTWARE VAD IS USED FOR TREATMENT NOT DIAGNOSIS. THREE BATTERIES ((B)(4)) 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. THE BATTERY (B)(4) PERFORMED PER SPECIFICATION; DEVICE PASSED VISUAL EXAMINATION AND FUNCTIONAL TESTING. ANALYSIS OF THE BATTERY (B)(4) REVEALED THAT THE DEVICE FAILED TO MEET SPECIFICATIONS. THE BATTERY FAILED FUNCTIONAL TESTING DUE TO A FAULTY INTERNAL CELL PAIR, WHICH LIKELY CONTRIBUTED TO THE REPORTED EVENT. TESTING OF BATTERY (B)(4) WAS NOT CONDUCTED AS TESTING AND INVESTIGATION OF SIMILAR BATTERY PERFORMANCE ISSUES WAS INVESTIGATED WITHIN AN INTERNAL INVESTIGATION AND CORRECTIVE ACTIONS WERE IMPLEMENTED. THERE ARE NO KNOWN CLINICAL FACTORS THAT COULD HAVE CONTRIBUTED TO THIS EVENT. A VOLUNTARY FIELD CORRECTION, FSCA APR2014, WAS INITIATED ON APRIL 30, 2014 REGARDING ALL HEARTWARE® VENTRICULAR ASSIST SYSTEM BATTERIES, PRODUCT CODES 1650 AND 1650-DE. THE FIELD CORRECTION PROVIDED PATIENTS AND HEALTHCARE PROVIDERS WITH INFORMATION TO RECOGNIZE BATTERIES WITH LESS THAN TWO HOURS OF RUN TIME, REEMPHASIZE INSTRUCTION ON ACTIONS TO TAKE WHEN BATTERY ALARMS OCCUR AND REINFORCE PROPER POWER MANAGEMENT. LABELING LANGUAGE ALSO WILL BE CLARIFIED TO ALIGN WITH THE INFORMATION CONTAINED IN THE FSCA APR2014 CORRECTION NOTICE. HEARTWARE LATER EXPANDED THE VOLUNTARY FIELD ACTION, FSCA APR2014.1, FOR THE REMOVAL OF UNSCREENED BATTERIES ((B)(4)) FROM THE FIELD. 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. (B)(4).

    Description of Event or Problem · 1

    APPROXIMATELY THREE YEARS POST HVAD IMPLANTATION THE SITE REPORTED THAT THE PATIENT EXPERIENCED POWER SOURCE CHANGE IN THE CONTROLLER EARLIER THAN EXPECTED. THE BATTERIES WERE REMOVED FROM THE PATIENT AND NEW BATTERIES WERE SUPPLIED. NO HARM OR INJURY TO THE PATIENT WAS REPORTED AS A RESULT OF THIS INCIDENT. INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650349 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE

    Patients

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