BEUDAMED
    FDA Adverse Event Other Summary report: N

    AVANTA FLUID MANAGEMENT SYSTEM

    MDR report key: 3865807 · Received May 28, 2014

    Report

    Report Number
    2520313-2014-00029
    Event Type
    Other
    Date Received
    May 28, 2014
    Date of Event
    May 4, 2014
    Report Date
    May 6, 2014
    Manufacturer
    BAYER MEDICAL CARE, INC
    Product Code
    DXT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SITE DECLINED A SYSTEM SERVICE CHECKOUT OF THE AVANTA FLUID MANAGEMENT SYSTEM. IN ADDITION, THE SITE WOULD NOT DISCLOSE INFO REGARDING THE DISPOSABLES USED DURING THE REPORTED INCIDENT. THE AVANTA FLUID MANAGEMENT SYSTEM HAS BEEN IN USE DAILY AT THE SITE SINCE THE REPORTED OCCURRENCE. ADD'L APPLICATIONS TRAINING WAS PROVIDED ON MAY 13, 2014.

    Description of Event or Problem · 1

    THE SITE REPORTED THE FOLLOWING TO A BAYER R & I REP: A PT SUFFERED AN ALLEGED AIR INJECTION WHILE CONNECTED TO THE AVANTA FLUID MANAGEMENT SYSTEM, SERIAL NUMBER (B)(4). THE PT BECAME UNSTABLE AND REQUIRED INTERVENTION WITH AN IABP (INTRA-AORTIC BALLOON PUMP). THE PT RECOVERED AND NO FURTHER MEDICAL OR SURGICAL INTERVENTION WAS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314742 AVANTA FLUID MANAGEMENT SYSTEM ANGIOGRAPHIC INJECTOR DXT BAYER MEDICAL CARE, INC AVA 500 PEDL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention