BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDRAD ANGIOGRAPHIC INJECTOR

    MDR report key: 1421830 · Received May 28, 2009

    Report

    Report Number
    2520313-2009-00021
    Event Type
    Other
    Date Received
    May 28, 2009
    Date of Event
    April 10, 2009
    Report Date
    May 28, 2009
    Manufacturer
    MEDRAD, INC.
    Product Code
    DXT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A MEDRAD SERVICE ENGINEER PERFORMED A CHECKOUT OF THE INJECTOR SYSTEM AND NO ISSUES WERE FOUND. THE DISPOSABLES THAT WERE IN USE DURING THE EVENT WERE NOT RETAINED BY THE CUSTOMER. EXTENSIVE ADDITIONAL TRAINING WAS PROVIDED TO THE STAFF ON (B)(4), 2009. EVIDENCE OF COMPETENCY DOCUMENTS WERE COMPLETED FOR THOSE IN ATTENDANCE.

    Description of Event or Problem · 1

    THE PT ARRIVED IN THE EMERGENCY DEPARTMENT WITH VENTRICULAR FIBRILLATION ARREST FROM AN UNK ETIOLOGY. THE PT WAS INTUBATED AND UNCONSCIOUS. DURING AN ANGIOGRAM, APPROXIMATELY 6-8 CCS OF AIR WAS SEEN IN THE LV. THE PT APPEARED TO HAVE SEIZURE ACTIVITY AND POSSIBLY SOME CARDIAC ARRHYTHMIAS WHICH RESOLVED WITHOUT INTERVENTION. THE PT DID NOT EXPERIENCE ANY LASTING AFFECTS FROM THIS AIR INJECTION. ONE OF THE TECHNOLOGISTS AT THE SITE THEORIZED THAT THE FLUID LINES WERE NOT PROPERLY PURGED OF AIR BEFORE PERFORMING THE INJECTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other