BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INJECTOR OPVSU NPS

    MDR report key: 18159608 · Received November 17, 2023

    Report

    Report Number
    1518293-2023-00034
    Event Type
    Malfunction
    Date Received
    November 17, 2023
    Report Date
    October 25, 2023
    Manufacturer
    LIEBEL-FLARSHEIM
    Product Code
    IZQ
    PMA / PMN Number
    K063503
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OVERALL INVESTIGATION SUMMARY: A GUERBET APPLICATIONS SPECIALIST REPORTED AN EXTRAVASATION EVENT OF AN UNKNOWN AMOUNT ON OPTIVANTAGE 849002 SERIAL NUMBER: (B)(6). THE CUSTOMER WAS CONDUCTING A CTA INJECTION OF 4ML/ SEC IN RIGHT AC REGION. THE CT SCANNER WAS TRIGGERED BY BOLUS AS EXPECTED, BUT THE IMAGES SHOWED INSUFFICIENT CONTRAST ENHANCEMENT. THE DOCTOR WHO WAS CALLED IN TO EXAMINE THE PATIENT APPLIED A PRESSURE DRESSING AND THEN STARTED A SECOND IV IN THE PATIENT'S LEFT WRIST REGION AND COMPLETED THE PROCEDURE WITHOUT FURTHER INCIDENT. THE PATIENT WAS RELEASED WITH POST EXTRAVASATION INSTRUCTION SHEET PER CUSTOMER'S STANDARD PROCEDURE. AS OF 10/31/23, NO PATIENT SIDE EFFECTS WERE REPORTED. THE CUSTOMER DID NOT REQUEST GUERBET SERVICE TO CHECK OUT THE INJECTOR INVOLVED WITH THIS EXTRAVASATION AND THE INJECTOR REMAINED IN CUSTOMER USE. A REVIEW OF GUERBET'S COMPLAINT TRACKING SYSTEM SHOWS NO SIMILAR ISSUE REPORTED ON THIS UNIT. EXTRAVASATIONS OR INFILTRATIONS ARE KNOWN POSSIBLE ADVERSE EFFECTS OF INTRAVENOUS INJECTIONS. EXTRAVASATIONS ARE GENERALLY USER RELATED IN NATURE. WHILE THE INJECTOR DOES NOT HAVE THE CAPABILITY TO PREVENT OR DETECT AN EXTRAVASATION (INFILTRATION); HOWEVER, PRECAUTIONS TO MINIMIZE AN EXTRAVASATION ARE PROVIDED IN THE OPERATOR'S MANUAL SEC. 4.1.1 RISKS/HAZARDS ASSOCIATED WITH THE DEVICE AND POTENTIAL SIDE EFFECTS/HARMS TO THE PATIENTS. IMPACT ASSESSMENT SUMMARY: PATIENT EXPERIENCED EXTRAVASATION, HAD A PRESSURE DRESSING APPLIED TO THE SITE. IMDRF CODES:B01; C20; D14. ROOT / PROBABLE CAUSE CODE: UNKNOWN. ROOT / PROBABLE CAUSE SUMMARY: REFER TO INVESTIGATION SUMMARY. AS SERVICE FOUND NOTHING WRONG WITH THE DEVICE DURING INVESTIGATION, NO CORRECTIVE ACTION WAS POSSIBLE. ALTHOUGH NO ADDITIONAL CAPA IS 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 REVIEW MEETINGS TO CONSIDER INPUT FOR ADDITIONAL CORRECTIVE ACTION. DISPOSITION SUMMARY: UNIT REMAINED IN SERVICE.

    Description of Event or Problem · 0

    THIS INCIDENT WAS REPORTED BY A FACILITY IN (B)(6) ON (B)(6) 2023. GUERBET EMPLOYEE ONSITE AT REPORTING FACILITY REPORTED A CTA INJECTION OF 4ML/ SEC IN RIGHT AC REGION. CT SCANNER WAS TRIGGERED BY BOLUS AS EXPECTED. IMAGES SHOWED INSUFFICIENT CONTRAST ENHANCEMENT. EXTRAVASATION WAS SUSPECTED OF UNKNOWN AMOUNT. DOCTOR CALLED IN TO EXAMINE. ( HE WAS IN CONSOLE ROOM). IT APPEARS TO HAVE A PRESSURE DRESSING APPLIED. DOCTOR STARTED SECOND IV IN LEFT WRIST REGION. SECOND INJECTION WAS GREAT. EXAM COMPLETED. PATIENT RELEASED WITH POST EXTRAVASATION INSTRUCTION SHEET AS IS THE ROUTINE IN USA HEALTHCARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330247 INJECTOR OPVSU NPS INJECTOR OPVSU NPS IZQ LIEBEL-FLARSHEIM 849002

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown