BEUDAMED
    FDA Adverse Event Other Summary report: N

    AVANTA FLUID MANAGEMENT SYSTEM

    MDR report key: 4379928 · Received December 30, 2014

    Report

    Report Number
    2520313-2014-00065
    Event Type
    Other
    Date Received
    December 30, 2014
    Date of Event
    December 5, 2014
    Report Date
    December 5, 2014
    Manufacturer
    BAYER MEDICAL CARE, INC.
    Product Code
    DXT
    PMA / PMN Number
    K050456
    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 PERFORMED ON (B)(6) 2014. THE SYSTEM WAS FOUND TO PERFORM TO SPECIFICATION. THE DISPOSABLES IN USE DURING THE PROCEDURE WAS DISCARDED BY THE SITE AND UNAVAILABLE FOR EVALUATION. THE LOT NUMBERS OF THE DISPOSABLES IN USE DURING THE PROCEDURE WERE ALSO UNAVAILABLE. ADDITIONAL APPLICATIONS TRAINING WAS OFFERED TO THE SITE WITH NO RESPONSE AT THIS TIME. IN THE EVENT ADDITIONAL INFORMATION IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED: A PATIENT SUFFERED AN ALLEGED AIR INJECTION WHILE ATTACHED TO THE AVANTA FLUID MANAGEMENT SYSTEM. THE PATIENT EXPERIENCED CARDIAC ARREST AND REQUIRED INTERVENTION. THERE IS LIMITED INFORMATION PROVIDED BY THE SITE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858236 AVANTA FLUID MANAGEMENT SYSTEM ANGIOGRAPHIC INJECTOR DXT BAYER MEDICAL CARE, INC. AVA 500 TABL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention