BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRAVASATION DETECTOR SYSTEM

    MDR report key: 1380825 · Received March 21, 2009

    Report

    Report Number
    2520313-2009-00011
    Event Type
    Malfunction
    Date Received
    March 21, 2009
    Date of Event
    January 22, 2009
    Report Date
    March 21, 2009
    Manufacturer
    MEDRAD, INC.
    Product Code
    DXT
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDRAD SERVICE WENT TO THE SITE TO CHECK OUT THE STELLANT INJECTOR AND THE XDS. NO ISSUES WERE FOUND WITH THE STELLANT INJECTOR. TESTING OF THE EXTRAVASATION DETECTOR'S SCAN ROOM MODULE DETERMINED THAT THE PRODUCT DID NOT PASS ALL FUNCTIONAL TESTING, SO THE SCAN ROOM MODULE WAS RETURNED TO MEDRAD FOR FURTHER ANALYSIS. A FOLLOW-UP REPORT WILL BE SUBMITTED, ONCE THE FINAL INVESTIGATION IS COMPLETE. ADDITIONAL APPLICATION'S TRAINING WAS PERFORMED WITH THE CT STAFF.

    Description of Event or Problem · 1

    AN OUTPATIENT WAS SCHEDULED FOR A CT SCAN. AN IV WAS STARTED IN THE RIGHT ANTECUBITAL VEIN. THE PT WAS THEN CONNECTED TO A STELLANT D INJECTOR AND THE EXTRAVASATION DETECTOR (XDS). THERE WERE NO ISSUES WITH THE IV AT THE START OF THE INJECTION. THE IV WAS FINE DURING THE SALINE TEST INJECTION AND THE SUBSEQUENT CONTRAST INJECTION. THE TECHNOLOGIST LEFT THE ROOM FOR THE SCAN TO START. NO COMPLAINT FROM PT. WHEN THE TECHNOLOGIST WENT BACK INTO THE ROOM AFTER THE CT SCAN WAS COMPLETE, THERE WAS A LUMP UNDER THE PT SENSOR. THE SITE REPORTED THAT THE EXTRAVASATION WAS APPROXIMATELY 20-30CCS OF SALINE THAT OCCURRED DURING THE SALINE FLUSH (LAST INJECTION PHASE), BECAUSE THE CT IMAGES WERE FINE. THE CUSTOMER REPORTED THAT THE XDS DID NOT DETECT THE SALINE FLUSH EXTRAVASATION. THE PT WAS DISCHARGED WITH INSTRUCTIONS TO APPLY HEAT AND ICE. THE PT DID NOT REQUIRE ANY FURTHER TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTRAVASATION DETECTOR SYSTEM EXTRAVASATION DETECTOR DXT MEDRAD, INC. 3014172 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR