BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAMIC CLEARACIL

    MDR report key: 6922097 · Received October 6, 2017

    Report

    Report Number
    MW5072632
    Event Type
    Injury
    Date Received
    October 6, 2017
    Date of Event
    September 12, 2017
    Report Date
    October 4, 2017
    Manufacturer
    NAVILYST MEDICAL INC./ ANGIODYNAMICS, INC.
    Product Code
    DQO
    UDI-DI
    H965910313030
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WAS HAVING A CARDIAC ANGIOGRAM, ALL TUBING AND MED RAD INJECTOR WAS PRIMED AND BACK PRIMED. CONTRAST WAS INJECTED AND PT STARTED TO LOSE B/P AND HR AND THEN CODED. THE PATIENT WAS TAKEN TO ICU ON REVIEW OF THE CATH FILMS THE NEXT MORNING, IT WAS DETERMINED THAT THE PATIENT HAD AN AIR EMBOLISM. THE TUBING THAT HAD BEEN USED DURING THE PROCEDURE HAD BEEN DISCARDED AND THE TEAM WAS NOT ABLE TO INSPECT FOR DAMAGE OR IF CONNECTIONS WERE SEALED AFTER CONTRAST HAD BEEN INJECTED THROUGH THE TUBING. THE INJECTOR WAS REMOVED FROM SERVICE AND CHECKED OUT AND FOUND TO BE WORKING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705179 NAMIC CLEARACIL CONTRAST INJECTION LINE DQO NAVILYST MEDICAL INC./ ANGIODYNAMICS, INC. 5058013 H965910313030

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Life Threatening| S