BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 5171702 · Received October 23, 2015

    Report

    Report Number
    3007042319-2015-02568
    Event Type
    Malfunction
    Date Received
    October 23, 2015
    Date of Event
    May 14, 2014
    Report Date
    May 14, 2014
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Removal / Correction Number
    Z-1698-2015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HVAD IS USED FOR TREATMENT NOT DIAGNOSIS. IT WAS REPORTED THAT THE PINS WERE DAMAGED ON PORT #1 AND NEITHER THE BATTERY NOR THE AC ADAPTER CAN BE CONNECTED TO THE CONTROLLER. THERE WAS NO REPORTED PATIENT INJURY RELATED TO THIS EVENT. THE CONTROLLER ((B)(4)) WAS RETURNED TO THE MANUFACTURER FOR VISUAL EVALUATION. ANALYSIS OF THE RETURNED CONTROLLER REVEALED THAT THE DEVICE FAILED VISUAL INSPECTION AS A RESULT OF DAMAGED PINS ON POWER PORT ONE (1). THE MOST PROBABLE ROOT CAUSE OF THE REPORTED POOR MECHANICAL CONNECTION MAY BE ATTRIBUTED TO DAMAGE TO THE PINS ON THE POWER SOURCE CONNECTORS, LIKELY A RESULT OF IMPROPER HANDLING, MATERIAL DURABILITY AND ASSEMBLY INTERFERENCES. THE MANUFACTURER HAS OPENED AN INTERNAL INVESTIGATION TO EVALUATE THESE TYPES OF ISSUES. A FIELD SAFETY NOTICE (FSCA APR2015A) WAS ISSUED TO CLINICIANS TO BE DELIVERED TO PATIENTS CURRENTLY ON DEVICE. IT PROVIDED AWARENESS, WARNINGS, AND SAFETY MITIGATIONS REGARDING WORN ALIGNMENT GUIDES RESULTING IN BENT PINS. THE FSCA INSTRUCTED PATIENTS TO INSPECT THE POWER SUPPLY PORTS ON THEIR CONTROLLERS FOR POTENTIAL WEAR OR DAMAGE TO THE ALIGNMENT GUIDES OR CONNECTION PINS. 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 OUTLINE THE STEPS FOR HANDLING AND PROPERLY CONNECTING POWER SOURCES, INCLUDING ENSURING PROPER ALIGNMENT, AS WELL AS INSTRUCTIONS NOT TO TWIST OR FORCE CONNECTIONS TOGETHER IN ORDER TO PREVENT DAMAGES. IT IS OUTLINED TO INSPECT THE POWER CONNECTIONS AND PINS ONCE A WEEK, ONE AT A TIME WHEN CHANGING THE POWER SOURCE. ADDITIONALLY THERE IS A WARNING TO KEEP SPARE, FULLY CHARGED BATTERIES AND BACK UP CONTROLLER AVAILABLE AT ALL TIME WITH A WARNING TO SWITCH TO THE BACK-UP CONTROLLER IF THERE IS A CONTROLLER FAILURE THE STEPS FOR EXCHANGE OF DEVICES ARE ALSO OUTLINED. IT FURTHER WARNS THAT DAMAGED EQUIPMENT SHOULD BE REPORTED TO THE MANUFACTURER AND INSPECTED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM THE UNITED STATES THAT THE CONTROLLER HAD A DAMAGED PIN WITHIN POWER PORT ONE (1) AND THE PATIENT WAS UNABLE TO CONNECT A POWER SOURCE. A CONTROLLER EXCHANGE WAS PERFORMED. THE DEVICE WAS REMOVED FROM SERVICE AND THE PATIENT WAS ISSUED A REPLACEMENT DEVICE. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. THERE WAS NO REPORTED PATIENT INJURY AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701874 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1