BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM - CONTROLLER 1.0

    MDR report key: 6946277 · Received October 12, 2017

    Report

    Report Number
    3007042319-2017-03716
    Event Type
    Malfunction
    Date Received
    October 12, 2017
    Date of Event
    December 11, 2015
    Report Date
    December 11, 2015
    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

    ONE CONTROLLER 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. ANALYSIS OF THE DEVICE REVEALED THAT THE DEVICE MET SPECIFICATIONS; THE DEVICE PASSED VISUAL EXAMINATION AND FUNCTIONAL TESTING. THE REPORTED EVENT WAS CONFIRMED VIA REVIEW OF THE CONTROLLER LOG FILES, WHICH REVEALED FIVE ELECTRICAL FAULT ALARMS DUE TO 'SYS-FRONT-PHASE-B-OPEN' FAULTS, INDICATIVE THAT THE PUMP WAS RUNNING ON SINGLE STATOR. THESE TYPE OF ALARMS ARE ASSOCIATED IN THE RISK DOCUMENTATION TO MULTIPLE POTENTIAL CAUSES SUCH AS DRIVELINE CONNECTOR MALFUNCTION, ELECTRICAL COMPONENT FAILURE AND FOREIGN MATERIAL INSIDE OF THE DRIVELINE CONNECTOR. HOWEVER, NONE OF THEM COULD BE VERIFIED AT THE BENCH LEVEL. IN ADDITION, LOG ANALYSIS REVEALED MULTIPLE CRITICAL BATTERY ALARMS AND SEVERAL OCCURRENCES OF PREMATURE POWER SWITCHING PRIOR TO THE 25% THRESHOLD FOR BATTERY SERIALS (B)(4). THESE PREMATURE SWITCHING EVENTS AND CRITICAL BATTERY ALARMS WERE MOST LIKELY CAUSED BY A COMMUNICATION ERROR BETWEEN THE CONTROLLER AND BATTERIES. HEARTWARE HAS OPENED AN INTERNAL INVESTIGATION TO EVALUATE THESE TYPES OF ISSUES. THESE ARE INCIDENTAL FINDINGS AND NOT RELATED TO THE REPORTED EVENT. THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT CANNOT BE CONCLUSIVELY DETERMINED; THE CONTROLLER PERFORMED AS INTENDED AT THE BENCH LEVEL. THE INSTRUCTIONS FOR USE (IFU) AND PATIENT MANUAL INCLUDE A REFERENCE GUIDE FOR BOTH VISUAL AND TONE ALARMS INCLUDING POTENTIAL CAUSES AND ACTIONS TO TAKE. ADDITIONALLY THERE IS A WARNING TO KEEP SPARE, FULLY CHARGED BATTERIES AND BACK UP CONTROLLER AVAILABLE AT ALL TIME. THE STEPS FOR EXCHANGE OF BATTERIES AND CONTROLLERS ARE OUTLINED. THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. 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. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. THIS EVENT WAS ASSESSED AND IS BEING REPORTED AS PART OF A RETROSPECTIVE REVIEW OF EVENTS, WHICH WAS IN RESPONSE TO AN UPDATE TO THE MDR DECISION CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE PATIENT WAS CHANGING FROM SITTING TO LYING (IN BED), AN "ELECTRICAL FAULT" OCCURRED. THE CONTROLLER WAS EXCHANGED. THERE WAS NO EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725470 HEARTWARE® VENTRICULAR ASSIST SYSTEM - CONTROLLER 1.0 CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1