BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDRAD ANGIOGRAPHIC INJECTOR

    MDR report key: 1392390 · Received May 20, 2009

    Report

    Report Number
    2520313-2009-00018
    Event Type
    Death
    Date Received
    May 20, 2009
    Date of Event
    April 19, 2009
    Report Date
    May 20, 2009
    Manufacturer
    MEDRAD, INC.
    Product Code
    DXT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A MEDRAD SERVICE ENGINEER PERFORMED A CHECKOUT OF THE INJECTOR SYSTEM AND NO ISSUES WERE FOUND. THE SITE RETAINED THE DISPOSABLES THAT WERE ALLEGEDLY INVOLVED IN THE INCIDENT. RISK MANAGEMENT AT THE HOSPITAL INDICATED THAT THE EVALUATION OF THE DISPOSABLES WAS NOT NECESSARY, BECAUSE THEY KNEW WHAT HAPPENED AND THAT THE RETRAINING WOULD ADDRESS THE PROBLEM. THIS INCIDENT IS BEING ATTRIBUTED TO USER ERROR. EXTENSIVE ADDITIONAL APPLICATIONS TRAINING WAS PERFORMED AT THIS SITE AND TWO OTHER SITES IN THE SAME HOSPITAL SYSTEM. EVIDENCE OF COMPETENCY FORMS WERE FILLED OUT FOR THE INDIVIDUALS THAT WERE TRAINED.

    Description of Event or Problem · 1

    THE PT WAS SCHEDULED FOR A DIAGNOSTIC CORONARY ANGIOGRAM. DURING THE PROCEDURE, THE USER HAD TO REMOVE THE ORIGINAL SYRINGE THAT WAS INSTALLED ON THE SYSTEM AND REPLACE IT WITH A NEW SYRINGE. THE USER THEN ATTEMPTED TO FILL AND PURGE THE NEW SYRINGE WITHOUT DISCONNECTING THE PT FROM THE SYSTEM. AN AIR INJECTION ALLEGEDLY OCCURRED DURING THE FILL AND PURGE OF THE SECOND SYRINGE. THE PT EXPIRED. NO AUTOPSY WAS PERFORMED AND RISK MANAGEMENT WOULD NOT PROVIDE THE CAUSE OF DEATH. RISK MANAGEMENT AT THE SITE REVIEWED THE AVANTA INSTRUCTIONS FOR USE AND THE SYSTEM ITSELF, AND ACKNOWLEDGED THAT THE AVANTA INSTRUCTIONS ARE CLEAR THAT THE PT BE DISCONNECTED DURING SYSTEM SET-UP AND PURGE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death