BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 4200446 · Received October 24, 2014

    Report

    Report Number
    3007042319-2014-01134
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Date of Event
    June 26, 2014
    Report Date
    September 26, 2014
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Removal / Correction Number
    Z-1607-2014, Z-1604-2015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HEARTWARE VENTRICULAR ASSIST DEVICE (VAD) IS USED FOR TREATMENT NOT DIAGNOSIS. IT WAS REPORTED THAT THE PATIENT EXPERIENCED POWER SWITCHING FROM ONE PORT TO THE OTHER EARLIER THAN EXPECTED. A CONTROLLER AND FOUR BATTERIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. EVALUATION OF THE DEVICES REVEALED THE FOLLOWING THAT BATTERIES AND CONTROLLER ((B)(4)) PERFORMED PER SPECIFICATION AT THE BENCH AND PASSED ALL EXTERNAL VISUAL INSPECTIONS BATTERY ((B)(4)) PASSED EXTERNAL VISUAL INSPECTION BUT FAILED FUNCTIONAL TESTING. IT WAS NOTED THAT THE CABLE CONNECTIONS TO THE PRINTED CIRCUIT ASSEMBLY (PCA) WERE SOMEWHAT LACKING SUFFICIENT SOLDER; IMPROPER ASSEMBLY OF THE CABLE ASSEMBLY ONTO THE PRINTED CIRCUIT ASSEMBLY (PCA) CAUSED THE BATTERY MALFUNCTION. THIS WAS AN INCIDENTAL FINDING AND NOT RELATED TO THE REPORTED EVENT. THE REPORTED EVENT COULD NOT BE CONFIRMED VIA LOG FILE ANALYSIS AS BATTERY IDS WERE NOT AVAILABLE. THE MOST PROBABLE ROOT CAUSE MAY BE ATTRIBUTED TO A COMMUNICATION ERROR BETWEEN THE CONTROLLER AND BATTERY IN ADDITION TO THE FAULTY SOLDER. THE MANUFACTURER HAS AN OPEN INTERNAL INVESTIGATION TO EVALUATE THIS TYPES OF ISSUES. ON APRIL 30, 2014, HEARTWARE ISSUED A FIELD SAFETY NOTICE (FSCA APR2014)/ RC-2014-RN-00510-1 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" IN WHICH PATIENTS WERE ADVISED TO TREAT ALL BATTERY ALARMS IN ACCORDANCE WITH THE PATIENT MANUAL AND IFU. 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. CONTROLLER AND BATTERIES RECEIVED ON (B)(4) 2014. (B)(4).

    Additional Manufacturer Narrative · 1

    THE HVAD REMAINS IMPLANTED IN THE PATIENT, THEREFORE, IT WILL NOT BE RETURNED. HOWEVER, THE CONTROLLER AND BATTERIES ((B)(4)) HAVE BEEN RECEIVED AND ARE AWAITING FURTHER ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY (30) DAYS OF RECEIPT. PRODUCT REMAINS IMPLANTED.

    Description of Event or Problem · 1

    APPROXIMATELY FIVE MONTHS POST HVAD IMPLANTATION, IT WAS REPORTED THAT THE PATIENT EXPERIENCED POWER SWITCHING FROM ONE PORT TO THE OTHER EARLIER THAN EXPECTED. ALL THE BATTERIES AND THE CONTROLLER WERE REPLACED AND RETURNED TO HEARTWARE FOR EVALUATION. THERE WAS NO REPORTED PATIENT INJURY AS A RESULT OF THIS EVENT; THE ISSUE WAS RESOLVED WITH REPLACEMENT DEVICES. THREE OF THE FOUR BATTERIES PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING, BUT (B)(4) FAILED FUNCTIONAL TESTING DUE TO AN ASSEMBLY PROBLEM. INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678734 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