BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 3022887 · Received March 27, 2013

    Report

    Report Number
    3007042319-2013-00043
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    February 25, 2013
    Report Date
    February 28, 2013
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED TO HEARTWARE. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE PUMP IN RELATION TO THE REPORTED EVENT. THESE INCLUDED CLINICAL NARRATIVE, REVIEW OF MANUFACTURING DOCUMENTATION, VISUAL AND FUNCTIONAL EXAMINATION, AND REVIEW OF CONTROLLER LOG FILES BY HEARTWARE. THE LOG FILES INDICATED THAT THERE WAS A SLIGHT INCREASE IN FLOW AND POWER, WHICH MAY BE CONSISTENT WITH THROMBUS FORMATION. HOWEVER, THROMBUS WAS NOT IDENTIFIED BY INDEPENDENT PATHOLOGICAL ANALYSIS. REVIEW OF THE MANUFACTURING DOCUMENTATION CONFIRMED THAT (B)(4) MET ALL REQUIREMENTS FOR RELEASE. POST EXPLANT ENGINEERING EVALUATION DID NOT REVEAL ANY CONDITIONS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. CLINICAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT WERE NOT PROVIDED BY THE SITE. BASED ON THE LIMITED INFORMATION PROVIDED, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT RELATES TO A DEVICE DEFECT. NO ADDITIONAL INFORMATION WILL BE FORTHCOMING

    Additional Manufacturer Narrative · 1

    THE DEVICE IS AVAILABLE FOR EVALUATION, BUT HAS NOT BEEN RECEIVED BY THE MANUFACTURER. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY (30) DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THIS EVENT INVOLVED A PATIENT WHO EXPERIENCED A PUMP EXCHANGE DUE TO A HIGH POWER EVENT APPROXIMATELY 2 MONTHS AND 22 DAYS POST HEARTWARE LVAD IMPLANTATION. ADDITIONAL INVESTIGATION IS ON-GOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126359 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening