BEUDAMED
    FDA Adverse Event Other Summary report: N

    AVANTA FLUID MANAGEMENT SYSTEM

    MDR report key: 3840754 · Received May 12, 2014

    Report

    Report Number
    2520313-2014-00026
    Event Type
    Other
    Date Received
    May 12, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 17, 2014
    Manufacturer
    BAYER MEDICAL CARE, INC.
    Product Code
    DXT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A BAYER FIELD SERVICE ENGINEER PERFORMED A SYSTEM SERVICE CHECKOUT OF THE AVANTA FLUID MANAGEMENT SYSTEM, SERIAL NUMBER (B)(4) ON (B)(6) 2014 AND THE UNIT WAS FOUND TO BE OPERATING TO SPECIFICATION. THE DISPOSABLES FROM THE ALLEGED INCIDENT WERE DISCARDED AND NOT AVAILABLE FOR EVALUATION. IN ADDITION, THE SITE WAS UNABLE TO PROVIDE LOT NUMBERS IN USE DURING THE ALLEGED INCIDENT. THE AVANTA FLUID MANAGEMENT SYSTEM HAS BEEN IN USE DAILY AT THE SITE SINCE THE REPORTED OCCURRENCE. NO ADDITIONAL APPLICATIONS TRAINING WAS DESIRED BY THE CUSTOMER.

    Description of Event or Problem · 1

    THE SITE REPORTED THE FOLLOWING TO A BAYER R & I REPRESENTATIVE: A MALE PATIENT SUFFERED A CARDIAC ARREST WHILE CONNECTED TO THE AVANTA FLUID MANAGEMENT SYSTEM, SERIAL NUMBER (B)(4). THE PATIENT BECAME ASYSTOLIC FOLLOWING THE FIRST INJECTION INTO THE LAD (LEFT ANTERIOR DESCENDING) ARTERY. AN AIR EMBOLISM WAS VISUALIZED IN THE LCA (LEFT CORONARY ARTERY). THE PATIENT REQUIRED CARDIOPULMONARY RESUSCITATION (CPR) FOR A BRIEF PERIOD AND THEN RECOVERED. HE WAS AWAKE, ORIENTED AND STABLE AFTER THE PROCEDURE. NO FURTHER MEDICAL OR SURGICAL INTERVENTION WAS NEEDED. THE PHYSICIAN THAT PERFORMED THE PROCEDURE STATED THAT THE INCIDENT WAS DUE TO USER ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283334 AVANTA FLUID MANAGEMENT SYSTEM ANGIOGRAPHIC INJECTOR DXT BAYER MEDICAL CARE, INC. AVA 500 PEDL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention