BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INJECTOR OPVSU SI NPS

    MDR report key: 21567428 · Received March 10, 2025

    Report

    Report Number
    1518293-2025-00002
    Event Type
    Injury
    Date Received
    March 10, 2025
    Date of Event
    February 6, 2025
    Report Date
    March 10, 2025
    Manufacturer
    LIEBEL-FLARSHEIM
    Product Code
    IZQ
    UDI-DI
    10746190002901
    PMA / PMN Number
    K063503
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OVERALL INVESTIGATION SUMMARY SERVICE INVESTIGATED CUSTOMER REPORT OF AN AIR BUBBLE PROBLEM. SERVICE FOUND NO ALARM FAULTS, AND OBSERVED NO PROBLEMS DURING TESTING OF THE UNIT. THE USER WAS ADVISED TO DECREASE THE FILLING SPEED FROM MAX TO MIN. THE UNIT WAS TESTED FOR PERFORMANCE AND RETURNED TO SERVICE. INJECTOR COMPLIANT. A REVIEW OF CTS SHOWS NO SIMILAR ISSUE REPORTED ON THIS UNIT. IMPACT ASSESSMENT SUMMARY NO INJURY TO THE PATIENT/USER REPORTED IMDRF CODES: B01; C23; D11 ROOT / PROBABLE CAUSE CODE PROCESS/METHODS - INADEQUATE/INCORRECT PROCEDURE ROOT / PROBABLE CAUSE SUMMARY REFER TO INVESTIGATION SUMMARY. NO ADDITIONAL CAPA REQUIRED AT THIS TIME. GUERBET QUALITY WILL CONTINUE TO MONITOR AND TREND FOR SIMILAR ISSUES. THESE TRENDS AND ISSUES ARE REPORTED ON DURING QUALITY METRICS REVIEW AND DURING THE MANAGEMENT REVIEWS TO CONSIDER INPUT FOR ADDITIONAL CORRECTIVE ACTION. DISPOSITION SUMMARY UNIT REMAINED IN SERVICE.

    Description of Event or Problem · 0

    THIS CASE WAS REPORTED BY A FACILITY IN FRANCE ON 10 FEBRUARY 2025. CUSTOMER STATES THAT ON (B)(6) 2025 THAT AFTER THE INJECTION USING THE OPTIVANTAGE INJECTOR, AIR WAS INJECTED. INCIDENT AT THE IMAGERIE MEDICALE LEVALLOIS PERRET SCANNER CENTRE. DURING A COROSCANNER AT 15:59, AIR BUBBLES WERE INJECTED, DETECTED BY THE RADIOLOGIST. THESE BUBBLES DID NOT APPEAR IN THE CALCIUM SCORE (ACQUISITION OF THE CALCIUM SCORE THEN AUTOMATIC INJECTION FOR THE ACQUISITION OF THE HEART). THE PATIENT WAS PLACED ON A STRETCHER IN DORSAL DECUBITUS POSITION AND GIVEN OXYGEN AT 15 UNTIL THE ARRIVAL OF THE AMBULANCE. THE PATIENT'S BLOOD PRESSURE WAS GOOD (14/7) AND SHE WAS FEELING WELL. SHE WAS TRANSFERRED TO GARCHES AND PLACED IN A HYPERBARIC CHAMBER. ON ARRIVAL FOR EXAMINATION, THE PATIENT HAD A SLIGHTLY ELEVATED HEART RATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2031565 INJECTOR OPVSU SI NPS INJECTOR OPVSU SI NPS IZQ LIEBEL-FLARSHEIM 849001 10746190002901

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other