BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 3022723 · Received March 27, 2013

    Report

    Report Number
    3007042319-2013-00023
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 26, 2013
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Removal / Correction Number
    3007042319-01/18/13-001C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT WAS VISUALLY CONFIRMED IN THE FIELD AND WAS ADDRESSED BY THE SITE PERSONNEL. NO FURTHER ACTION IS REQUIRED. NO ADDITIONAL INFORMATION WILL BE FORTHCOMING.

    Additional Manufacturer Narrative · 1

    THE PRODUCT REMAINS IMPLANTED IN THE PATIENT, THEREFORE, IT WILL NOT BE RETURNED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY.

    Description of Event or Problem · 1

    APPROXIMATELY 3 YEARS AND 6 MONTHS POST HEARTWARE LVAD IMPLANTATION, DURING THE EXAMINATION OF THE DRIVELINE CABLE FOR THIS PATIENT, THE CONNECTOR WAS FOUND TO BE LOOSE. THIS FINDING WAS IDENTIFIED AS A RESULT OF THE TECHNICAL BULLETIN (3007042319-01/18/13-001-C) ISSUED ON 18/01/2013 BY HEARTWARE INC. FOR THIS MATTER. THE DRIVELINE CABLE CONNECTOR COULD NOT BE COMPLETELY UNSCREWED AND REMOVED, SO THE SITE PERSONNEL FULLY TIGHTENED THE CONNECTOR WITH A WRENCH. THE SITE DISCUSSED THE ISSUE WITH HEARTWARE PERSONNEL AND IT WAS DETERMINED THAT NO FURTHER ACTION WAS REQUIRED. THE EVENT WAS RESOLVED WITHOUT PATIENT INJURY. THE SITE WILL CONTINUE TO MONITOR THE PATIENT'S DRIVELINE CABLE CONNECTOR DURING ROUTINE VISITS AND WILL CONSULT WITH HEARTWARE IF FURTHER ACTION IS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125661 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM, DRIVELINE DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1