BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INJECTOR OPVSU SI NPS

    MDR report key: 15649727 · Received October 21, 2022

    Report

    Report Number
    1518293-2022-00014
    Event Type
    Malfunction
    Date Received
    October 21, 2022
    Date of Event
    September 26, 2022
    Report Date
    September 26, 2022
    Manufacturer
    LIEBEL-FLARSHEIM
    Product Code
    IZQ
    PMA / PMN Number
    K063503
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OVERALL INVESTIGATION SUMMARY- FSE CONFIRMED THAT THE INJECTOR OVER PRESSURES DURING INJECTION, INVESTIGATED AND THAT A RIBBON HARNESS ASSY. HAD BECOME LOOSE CREATING INTERMITTENT PROBLEMS, INCLUDING PRESSURE LIMITING. FSE SECURED THE CABLE AND CHECKED ALL OTHER CONNECTIONS. FSE THEN VERIFIED OPERATION ACCORDING TO OPTIVANTAGE DUAL-HEAD CT CONTRAST DELIVERY SYSTEM V-5 AND ABOVE TEST AND INSPECTION DATA CHECKLIST (B)(4) AND RETURNED THE UNIT TO SERVICE. 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; C0205; D02. ROOT / PROBABLE CAUSE CODE- EQUIPMENT/INSTRUMENT - FAILURE. 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 RETURNED TO SERVICE.

    Description of Event or Problem · 0

    THIS INCIDENT WAS REPORTED BY A FACILITY IN (B)(6) ON (B)(6) 2022. THE REPORTER STATES THAT CTE AND PE WERE OVER PRESSURE AS SOON AS THEY ATTEMPT TO INJECT IT. THERE WAS NO HARM OR RISK TO PATIENT REPORTED, AND THE PROCEDURE WAS NOT COMPLETED. PRESSURE LIMIT WAS SET TO 325, 4-5ML/S, NEEDLE SIZE 18 OR 20 GA, MANUFACTURER OF SYRINGE IS GUERBET 200ML. THE REPORTER STATES THAT THIS HAS OCCURRED A PRIOR TIME AND WANT TO MAKE SURE THAT THE PRESSURE LIMIT IS PROPER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1647929 INJECTOR OPVSU SI NPS INJECTOR OPVSU SI NPS IZQ LIEBEL-FLARSHEIM 849001 C0821B544G

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown