BEUDAMED
    FDA Adverse Event Death Summary report: N

    AVANTA FLUID MANAGEMENT SYSTEM

    MDR report key: 4066776 · Received August 12, 2014

    Report

    Report Number
    2520313-2014-00042
    Event Type
    Death
    Date Received
    August 12, 2014
    Date of Event
    July 16, 2014
    Report Date
    July 16, 2014
    Manufacturer
    BAYER MEDICAL CARE INC.
    Product Code
    DXT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SYSTEM SERVICE CHECKOUT OF THE AVANTA FLUID MANAGEMENT SYSTEM WAS DECLINED BY THE CUSTOMER. THE DISPOSABLES IN USE DURING THE DIAGNOSTIC PORTION OF THE PROCEDURE WERE DISCARDED BY THE SITE AND UNAVAILABLE FOR EVAL. ADDITIONALLY, THE LOT NUMBERS OF THE DISPOSABLES IN USE DURING THE DIAGNOSTIC PORTION OF THE PROCEDURE WERE NOT DISCLOSED BY THE SITE. IN THE EVENT ADDITIONAL INFO IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A BAYER R AND I REPRESENTATIVE REPORTED THE FOLLOWING: A PT SUFFERED A CARDIAC ARREST DURING AN IMPLANTATION OF A ST. JUDE MEDICAL DEVICE. THE AVANTA FLUID MANAGEMENT SYSTEM WAS USED PRIOR TO THE IMPLANTATION TO VISUALIZE THE CARDIAC ANATOMY WITHOUT INCIDENT. THE ST. JUDE MESH DEVICE WAS THEN IMPLANTED AND THE PT ARRESTED. THE AVANTA WAS USED AGAIN APPROXIMATELY 20 MINUTES AFTER THE INCIDENT TO VISUALIZE THE VENTRICULAR ANATOMY OF THE HEART. THE PT WAS THEN TRANSFERRED TO THE INTENSIVE CARE UNIT IN POOR CONDITION. THE PT PASSED AWAY LATER THAT SAME DAY. THE TWO PHYSICIANS THAT PERFORMED THE PROCEDURE STATED THAT THE AVANTA FLUID MANAGEMENT SYSTEM WAS NOT RESPONSIBLE OR RELATED TO THE ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479169 AVANTA FLUID MANAGEMENT SYSTEM ANGIOGRAPHIC INJECTOR DXT BAYER MEDICAL CARE INC. AVANTA 500 PEDL

    Patients

    Seq Age Sex Outcome Treatment
    1 Death