BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 4123172 · Received September 26, 2014

    Report

    Report Number
    3007042319-2014-01006
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    September 17, 2014
    Report Date
    September 18, 2014
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HEARTWARE VAD IS USED FOR TREATMENT NOT DIAGNOSIS. CONTROLLER ((B)(4)) WAS RETURNED FOR EVALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICE IN RELATION TO THE REPORTED EVENT. THOROUGH EXTERNAL VISUAL INSPECTION OF THE DEVICE REVEALED NO SIGNS OF PHYSICAL DAMAGE OR CONTAMINATION. THE REPORTED EVENT WAS CONFIRMED VIA REVIEW OF THE CONTROLLER LOG FILES, WHICH REVEALED TWO "ELECTRICAL FAULT" ALARMS FOLLOWED BY A VAD STOP ALARM ON THE DATE OF THE REPORTED EVENT. IN BOTH CASES THE PUMP WAS ABLE TO SUCCESSFULLY RESTART AND RUN PROPERLY. PRIOR TO THE FIRST ELECTRICAL FAULT ALARM, THE LOG FILES REVEALED A CURRENT READING ABOVE THE NORMAL OPERATING RANGE. ABNORMAL CURRENT READINGS BEFORE AN ELECTRICAL FAULT ALARMS ARE MOST OFTEN ATTRIBUTED TO CONTAMINATION. ANALYSIS OF THE DEVICE REVEALED THAT THE DEVICE MET SPECIFICATIONS; THE CONTROLLER PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. THE REVIEW OF THE CONTROLLER LOG FILES SHOWS THAT THE NATURE OF THE ELECTRICAL FAULT ALARM, THE HIGH IMPEDANCE AND THE PROXIMITY OF THE IMPLANT DATE WERE INDICATIONS OF CONTAMINATION OF THE DRIVELINE CONNECTOR. APPLICABLE RISK DOCUMENTATION AND EXPERIENCE WITH EVENTS OF SIMILAR CIRCUMSTANCES WERE CONSIDERED; EVENTS WITH ELECTRICAL FAULTS ARE MOST OFTEN ATTRIBUTED TO CONTAMINATION OF THE DRIVELINE CONNECTOR. THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT IS CONTAMINATION OF THE DRIVELINE CONNECTOR. THE MANUFACTURER HAS OPENED AN INTERNAL INVESTIGATION TO EVALUATE THESE TYPES OF ISSUES. 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 (IFU) NOTE SPECIFICALLY STATES TO PROTECT THE DRIVELINE CONNECTOR OR IMPROPER USE OF THE DRIVELINE CAP COULD RESULT IN CONTAMINATION OR DAMAGE TO THE CONNECTOR AND ELECTRICAL FAULT ALARMS COULD OCCUR. WHILE THERE IS NO AVAILABLE INFORMATION AT THIS TIME TO INDICATE THE CAUSE OF THIS REPORTED EVENT, IT MAY BE POSSIBLE THAT FOREIGN MATERIAL WAS INTRODUCED INTO THE DRIVELINE CONNECTOR DURING THE IMPLANT PROCEDURE. 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. THIS REPORT MAY BE BASED ON INFORMATION WHICH HEARTWARE HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 1

    THE HVAD REMAINS IMPLANTED IN THE PATIENT, THEREFORE IT WILL NOT BE RETURNED. HOWEVER, THE CONTROLLER ((B)(4)) IS AVAILABLE FOR EVALUATION, BUT HAS 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

    SHORTLY AFTER HEARTWARE LVAD IMPLANTATION, IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF POWER TO THE PUMP AFTER THE CONTROLLER INDICATED AN ELECTRICAL FAULT. THE SITE PERFORMED AN EMERGENT CONTROLLER EXCHANGE RESULTING IN A PUMP RESTARTING SUCCESSFULLY. 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
    602676 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 CON186168_CONTROLLER