BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STELLANT DUAL CT INJECTION SYSTEM

    MDR report key: 1882460 · Received October 21, 2010

    Report

    Report Number
    2520313-2010-00034
    Event Type
    Injury
    Date Received
    October 21, 2010
    Date of Event
    September 21, 2010
    Report Date
    October 21, 2010
    Manufacturer
    MEDRAD
    Product Code
    DXT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SYSTEM SERVICE CHECK OF THE STELLANT INJECTOR VERIFIED THE INJECTOR WAS OPERATING WITHIN MEDRAD SPECIFICATIONS. ADDITIONAL APPLICATIONS TRAINING WAS COMPLETED ON (B)(6), 2010.

    Description of Event or Problem · 1

    THE SITE REPORTED THE FOLLOWING: THE PATIENT HAD AN ADMITTING DIAGNOSIS OR SHORTNESS OF BREATH. THE PATIENT WAS SCHEDULED FOR A CT ANGIOGRAM OF THE CHEST TO RULE OUT A PULMONARY EMBOLISM. THE PATIENT HAD A RIGHT ANTECUBITAL IV WHICH WAS STARTED IN THE EMERGENCY ROOM. THE IV SITE WAS VISUALLY MONITORED DURING A BOLUS INJECTION PERFORMED BY HAND AND A TEST BOLUS WAS PERFORMED WITH THE INJECTOR. POST INJECTION, THE PATIENT COMPLAINED OF PAIN. AN EXTRAVASATION OF APPROXIMATELY 100MLS OF CONTRAST AND 20-40MLS OF SALINE WAS NOTED AT THE INJECTION SITE LOCATION. THE PATIENT DEVELOPED COMPARTMENTAL SYNDROME REQUIRING SURGICAL REPAIR. THE PATIENT REPORTEDLY RECOVERED AND WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STELLANT DUAL CT INJECTION SYSTEM CT INJECTION SYSTEM DXT MEDRAD 3007301

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R