BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INJECTOR OPVSU SI NPS

    MDR report key: 20845318 · Received December 4, 2024

    Report

    Report Number
    1518293-2024-00024
    Event Type
    Injury
    Date Received
    December 4, 2024
    Date of Event
    November 7, 2024
    Report Date
    December 4, 2024
    Manufacturer
    LIEBEL-FLARSHEIM
    Product Code
    IZQ
    UDI-DI
    10746190002901
    PMA / PMN Number
    K063503
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OVERALL INVESTIGATION SUMMARY: CONSIDERING THE INCIDENT REPORTED ON (B)(6)2024 REGARDING THE INJECTOR AND THE APPLICATION OF CONTRAST, AS OF THE DATE OF THIS REPORT, THE FOLLOWING ACTIVITIES WERE CARRIED OUT ON-SITE: GENERAL INSPECTION OF THE EQUIPMENT. VERIFICATION OF RESULTS OBTAINED FROM THE STUDIES ON (B)(6)2024 (NO ACTIVATION OF ALARMS OR ISSUES OBSERVED IN THE INJECTION GENERATED BY THE EQUIPMENT). EXECUTION OF FUNCTIONAL TESTS WITHOUT OBSTRUCTING THE CONTRAST OUTPUT EXTENSION. EXECUTION OF FUNCTIONAL TESTS WITH OBSTRUCTION IN THE CONTRAST OUTPUT EXTENSION (IT IS OBSERVED THAT THE EQUIPMENT STOPS AND ALARMS UPON DETECTING OBSTRUCTION IN THE EXTENSION). CORRECT ACTIVATION OF THE PATENCY FUNCTIONS (FUNCTION THAT MEASURES THE PERMEABILITY OF THE VEIN). VERIFICATION OF THE SYRINGE ADAPTER HEATERS OF THE EQUIPMENT (THE HEATERS PREVENT THE CONTRAST AND SALINE SOLUTION FROM CRYSTALLIZING). ALL FUNCTIONS AND ELEMENTS OF THE EQUIPMENT WERE VERIFIED, AND NO ISSUES WERE FOUND; THE EQUIPMENT IS FUNCTIONING CORRECTLY.

    Description of Event or Problem · 0

    THIS CASE WAS REPORTED BY A FACILITY IN FRANCE ON (B)(6) 2024. CUSTOMER STATES THAT THE CONTRAST MEDIA WAS INFUSED INTO THE DERMIS. ON (B)(6)2024, AT 11PM, THEY RECEIVE FOR A CONTRAST CT SCAN, A 56-YEAR-OLD PATIENT WHO WAS IN ICU DUE TO A CAR ACCIDENT, UNSTABLE AND HYPERACTIVE, WHICH IS WHY THEY MUST IMMOBILIZE SINCE THERE WERE ATTEMPTS TO REMOVE THE VENOUS ACCESS, THE TECHNOLOGIST PERFORMS A TEST OF THE VEIN WITH 10ML OF SALINE SOLUTION AND ACTIVATES THE PATENCY CHECK INJECTOR OPTION, WITH WHICH THEY VERIFY THAT IT IS IN OPTIMAL CONDITION FOR THE EXAMINATION, FOR WHICH THEY PROCEED TO INJECT 80CC OF IOBITRIDOL WITH 40 CC OF SALINE SOLUTION, ACCORDING TO THE SERVICE, THE PATIENT LEAVES THE DIAGNOSTIC IMAGING AREA IN NORMAL CONDITIONS, HOWEVER IN ICU THEY REALIZE THAT HE HAS AN ABNORMALITY IN THE LEFT ARM. THEY SUBSEQUENTLY NOTIFY THE RADIOLOGIST WHO GIVES THE REQUIRED TREATMENT FOR THE CASE. (X-RAY OF THE LEFT UPPER EXTREMITY, COLD AND HOT WATER CLOTHS ON THE AFFECTED AREA).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1871409 INJECTOR OPVSU SI NPS INJECTOR OPVSU SI NPS IZQ LIEBEL-FLARSHEIM 849001 10746190002901

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Unknown