BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 3195513 · Received June 28, 2013

    Report

    Report Number
    3007042319-2013-00108
    Event Type
    Death
    Date Received
    June 28, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 21, 2013
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT GOING TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION; HOWEVER, ATTEMPTS TO UNDERSTAND WHY THE PRODUCT IS NOT BEING RETURNED ARE ON-GOING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY (30) DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT, DRIVELINE CONNECTOR DAMAGE, WAS CONFIRMED VISUALLY AT THE SITE BY THE HEARTWARE CLINICAL ENGINEER, WHO SAW THAT THE PINS WERE RECESSED FROM THE CONTACT BLOCK AND PERFORMED A DRIVELINE SPLICE REPAIR PROCEDURE. REVIEW OF THE MANUFACTURING DOCUMENTATION CONFIRMED THAT HW2577 MET ALL REQUIREMENTS FOR RELEASE. REVIEW OF THE LOG FILES CONFIRMED MULTIPLE VAD STOPPED/ VAD DISCONNECT AND ELECTRICAL FAULT ALARMS AROUND THE TIME OF THE EVENT. BASED ON THE REVIEW OF THE INFORMATION AVAILABLE, THE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. NO ADDITIONAL INFORMATION WILL BE FORTHCOMING.

    Description of Event or Problem · 1

    APPROXIMATELY 16 MONTHS AFTER INITIAL HEARTWARE LVAD IMPLANTATION, THIS PATIENT BECAME DISCONNECTED FROM HER CONTROLLER AND EXPERIENCED A VAD STOP. IT WAS REPORTED THAT THE PATIENT DROPPED HER CONTROLLER AND ALL THE PINS RECESSED OUT OF THE CONNECTOR BLOCK. SHE REQUIRED CARDIOPULMONARY RESUSCITATION, WAS PLACED ON EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT AND WAS TAKEN TO THE OPERATING ROOM. A HEARTWARE FIELD ENGINEER PERFORMED A DRIVELINE SPLICE REPAIR PROCEDURE AND THE PUMP RESTARTED. THE PATIENT EXPIRED THE SAME DAY. INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296840 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Death