BEUDAMED
    FDA Adverse Event Other Summary report: N

    AVANTA FLUID MANAGEMENT INJECTION SYSTEM

    MDR report key: 1674463 · Received April 30, 2010

    Report

    Report Number
    2520313-2010-00018
    Event Type
    Other
    Date Received
    April 30, 2010
    Date of Event
    April 1, 2010
    Report Date
    April 29, 2010
    Manufacturer
    MEDRAD, INC.
    Product Code
    DXT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE AVANTA INJECTOR WAS CHECKED BY A MEDRAD SERVICE REPRESENTATIVE AND WAS FUNCTIONING CORRECTLY. THE CUSTOMER DID NOT RETAIN THE DISPOSABLES THAT WERE IN USE DURING THE REPORTED INCIDENT; THEREFORE, THEY WERE NOT AVAILABLE FOR EVALUATION. OUR MEDRAD CLINICAL APPLICATIONS SPECIALIST VISITED THIS FACILITY AFTER THE REPORTED INCIDENT. DURING THIS VISIT, THE CLINICAL APPLICATIONS SPECIALIST OBSERVED THAT THE PRIMING INSTRUCTIONS CONTAINED IN THE OPERATION MANUAL WERE NOT BEING FOLLOWED BY SOME OF THE TECHNOLOGISTS. THIS WAS DISCUSSED WITH THE CHIEF NURSE AND SHE AGREED WITH THE MEDRAD REPRESENTATIVE. FURTHER APPLICATIONS TRAINING IS SCHEDULED.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE SITE REPORTED THE FOLLOWING: DURING THE FIRST INJECTION OF A CARDIAC CATHETERIZATION NO CONTRAST WAS SEEN IN THE LEFT CORONARY ARTERY AFTER A SMALL INJECTION WAS DONE TO VISUALIZE THE TIP OF THE CATHETER. THE SITE NOTED THAT FOR THE CARDIOLOGIST, THIS IS TYPICAL OF AN AIR INJECTION. THE PT REQUIRED BOTH RESPIRATORY AND CARDIAC RESUSCITATION. THE PT WAS THEN MOVED TO THE ICU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVANTA FLUID MANAGEMENT INJECTION SYSTEM ANGIOGRAPHIC INJECTOR DXT MEDRAD, INC. AVA 500 TABL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention