BEUDAMED
    FDA Adverse Event Death Summary report: N

    AVANTA SINGLE-PATIENT DISPOSABLE SET

    MDR report key: 1623090 · Received March 3, 2010

    Report

    Report Number
    2520313-2010-00012
    Event Type
    Death
    Date Received
    March 3, 2010
    Date of Event
    February 1, 2010
    Report Date
    March 3, 2010
    Manufacturer
    MEDRAD, INC.
    Product Code
    DXT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    A MEDRAD SERVICE ENGINEER PERFORMED A SYSTEM CHECK-OUT ON THE AVANTA FLUID MANAGEMENT INJECTION SYSTEM AND THE UNIT WAS FOUND TO BE OPERATING TO SPECIFICATION. THE SINGLE-PATIENT DISPOSABLE SET (SPAT) THAT WAS IN-USE DURING THE REPORTED EVENT WAS RETAINED BY THE CUSTOMER. WE ARE AWAITING THE RETURN OF THE DISPOSABLE FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED, ONCE THE DISPOSABLE IS RETURNED AND WE EVALUATE IT. ADDITIONAL APPLICATIONS TRAINING WAS PERFORMED OVER MULTIPLE DAYS AT THE SITE. DURING THE TRAINING, WE OBSERVED THAT THE STAFF WAS NOT PROPERLY PURGING THE DISPOSABLES AND FOLLOWING THE INSTRUCTIONS THAT WERE PROVIDED DURING TRAINING (WHICH ARE ALSO CONTAINED IN THE OPERATOR'S MANUAL). WE ATTEMPTED TO ADDRESS AND CORRECT THIS DURING THE ADDITIONAL APPLICATIONS TRAINING. IN ADDITION, DISPOSABLES FROM THE SAME LOT NUMBER THAT WERE IN-USE DURING THE REPORTED EVENT WERE USED DURING THE ADDITIONAL APPLICATIONS TRAINING WITHOUT INCIDENT. AFTER THE AVANTA INJECTOR WAS CHECKED BY MEDRAD SERVICE AND AFTER THIS APPLICATIONS TRAINING, THE SITE CONTINUED TO USE THE INJECTOR WITHOUT INCIDENT.

    Description of Event or Problem · 1

    THE SITE REPORTED THE FOLLOWING: DURING THE FIRST INJECTION OF THE PROCEDURE ON THE THIRD PATIENT OF THE DAY, AIR WAS INJECTED INTO THE LEFT CORONARY ARTERY. THE PATIENT WENT INTO HEART AND RESPIRATORY FAILURE, AND REQUIRED REANIMATION AND CIRCULATORY ASSISTANCE. THE PATIENT WAS THEN TRANSFERRED TO THE INTENSIVE CARE UNIT AND EXPIRED THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVANTA SINGLE-PATIENT DISPOSABLE SET ANGIOGRAPHIC TUBING SET DXT MEDRAD, INC. 3018355 720005

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Death AVANTA FLUID MANAGEMENT INJECTION SYSTEM