BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 3359934 · Received September 20, 2013

    Report

    Report Number
    3007042319-2013-00230
    Event Type
    Injury
    Date Received
    September 20, 2013
    Date of Event
    May 25, 2013
    Report Date
    August 21, 2013
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED IN THE FIELD BY HEARTWARE CLINICAL ENGINEERING PERSONNEL. THE PRODUCT REMAINS IMPLANTED IN THE PATIENT, THEREFORE, IT WILL NOT BE RETURNED. THE CONTROLLER WAS RETURNED TO HEARTWARE. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICE IN RELATION TO THE REPORTED EVENT. THE ELECTRICAL FAULT COMPLAINT WAS CONFIRMED BASED ON CONTROLLER LOGS. THE LOGS SHOW ELECTRICAL FAULTS ON THE REAR STATOR. FUNCTIONAL TESTING OF THE RETURNED CONTROLLER SHOWED IT RAN NORMALLY WITH NO FAULT ALARMS OR ERRORS. FOREIGN MATERIAL WAS FOUND IN THE CONTROLLER'S DRIVELINE PORT. AN INTERNAL INVESTIGATION (CAPA) HAS BEEN OPEN TO ADDRESS THE ISSUE. NO ADDITIONAL INFORMATION WILL BE FORTHCOMING.

    Additional Manufacturer Narrative · 1

    (B)(4). HEARTWARE IS SUBMITTING THIS CORRECTION TO A PREVIOUSLY SUBMITTED MDR 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 IS ONE OF TWO REPORTS (3007042319-2013-00230 AND 2016-02137) SUBMITTED FOR DEVICES RELATED TO THE SAME EVENT.

    Description of Event or Problem · 1

    THIS EVENT INVOLVED A PATIENT WHO EXPERIENCED ELECTRICAL FAULT ALARMS AND A VAD STOP APPROXIMATELY 40 DAYS POST HEARTWARE LVAD IMPLANTATION. THESE ALARMS HAD STARTED THE PREVIOUS EVENING AND THE PATIENT WAS TALKED THROUGH A CONTROLLER EXCHANGE OVER THE PHONE BY THE HOSPITAL STAFF. HEARTWARE FIELD CLINICAL ENGINEER SCHEDULED A DRIVELINE CLEANING PROCEDURE. DRIED WHITE CRYSTALLINE MATERIAL WAS SEEN IN THE PINS AND DRIED BLOOD WAS OBSERVED ON THE FACE OF THE CONNECTOR. INSPECTION OF THE DRIVELINE SHOWED PARTICULATES IN THE INNER LUMEN OF TWO WIRES (BLACK AND GREEN). PRELIMINARY LOGS FILES REVIEW SHOWED 18 ELECTRICAL FAULTS RESULTING IN A VAD STOP. AN ELECTIVE CONTROLLER EXCHANGE WAS PERFORMED BY A HEARTWARE FIELD CLINICAL ENGINEER WITHOUT PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475013 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1