BEUDAMED
    FDA Adverse Event Other Summary report: N

    AVANTA FLUID MANAGEMENT SYSTEM

    MDR report key: 3783533 · Received April 16, 2014

    Report

    Report Number
    2520313-2014-00021
    Event Type
    Other
    Date Received
    April 16, 2014
    Date of Event
    March 11, 2014
    Report Date
    March 27, 2014
    Manufacturer
    MEDRAD
    Product Code
    DXT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TD
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A BAYER R AND I SERVICE ENGINEER PERFORMED AN INJECTOR CHECKOUT OF THE AVANTA FLUID MANAGEMENT SYSTEM ON (B)(6) 2014 AND FOUND IT WAS FUNCTIONING TO SPECIFICATION. THE DISPOSABLES FROM THE ALLEGED INCIDENT WERE DISCARDED AND NOT AVAILABLE FOR EVALUATION. THE SITE PROVIDED LOT NUMBERS THAT WERE IN USE DURING THE ALLEGED INCIDENT. TESTING OF RETAIN SAMPLES SHOWED THE PRODUCT PERFORMED TO SPECIFICATION. THE AVANTA FLUID MANAGEMENT SYSTEM HAS BEEN IN USE DAILY AT THE SITE SINCE THE REPORTED OCCURRENCE. ADDITIONAL APPLICATIONS TRAINING WAS PERFORMED ON (B)(6) 2014.

    Description of Event or Problem · 1

    THE SITE REPORTED THE FOLLOWING TO A BAYER R AND I REPRESENTATIVE: A (B)(6) MALE PT WITH A KNOWN CARDIAC CONDITION, DIABETES, AND HYPERTENSION UNDERWENT A CORONARY ANGIOGRAM AND SUFFERED AN AIR INJECTION WHILE CONNECTED TO THE AVANTA FLUID MANAGEMENT SYSTEM. AN INDETERMINATE AMOUNT OF AIR WAS VISUALIZED IN THE LEFT CORONARY ARTERY FOLLOWING A TEST INJECTION. THE PT BECAME BRADYCARDIC AND SUFFERED A CARDIAC ARREST. THE PT REQUIRED MEDICAL INTERVENTION INCLUDING CHEST COMPRESSIONS, ATROPINE AND ADRENALINE. THE PT RECOVERED AND WAS DISCHARGED TWO DAYS FOLLOWING THE PROCEDURE. NO FURTHER TREATMENT WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233885 AVANTA FLUID MANAGEMENT SYSTEM ANGIOGRAPHIC INJECTOR DXT MEDRAD AVA 500 PEDL

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention