BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INJECTOR OPVSU NPS

    MDR report key: 17710999 · Received September 8, 2023

    Report

    Report Number
    1518293-2023-00023
    Event Type
    Malfunction
    Date Received
    September 8, 2023
    Date of Event
    August 17, 2023
    Report Date
    August 17, 2023
    Manufacturer
    LIEBEL-FLARSHEIM
    Product Code
    IZQ
    PMA / PMN Number
    K063503
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OVERALL INVESTIGATION SUMMARY A COMPLAINT WAS RECEIVED ON OPTIVANTAGE INJECTOR PART NUMBER 849002 SERIAL NUMBER C0123B678G ALLEGING INFILTRATIONS ON TWO (2) PATIENTS. THE CUSTOMER CT TECH BELIEVES THAT WHEN A VEIN BLOWS AND AN INFILTRATION IS OCCURRING, THE INJECTOR SHOULD SENSE THIS BECAUSE THE PRESSURE WILL INCREASE OR SPIKE AND EITHER ALERT THE OPERATOR OR STOP THE INJECTION. AS THE INJECTOR DIDN'T, THE CUSTOMER INSISTS THERE IS SOMETHING WRONG WITH THE INJECTOR. TECH SUPPORT EXPLAINED THAT THE INJECTOR CANNOT DETECT AN INFILTRATION AND ALSO EXPLAINED THAT IF THE INJECTED FLUID WENT INTO THE EPIDERMIS WITH NO RESTRICTION, THEN THE PRESSURE WOULD NOT HAVE RAISED. THE CUSTOMER CT TECH ASKED THAT A FIELD SERVICE ENGINEER (FSE) CHECK OUT THE INJECTOR, TO VERIFY THE PRESSURES ARE WITHIN TOLERANCE. CUSTOMER WAS INTERESTED IN LEARNING ABOUT THE PATENCY CHECK FEATURE AS THE CUSTOMER DOES NOT CURRENTLY USE IT. FIELD SERVICE WAS DISPATCHED TO THE CUSTOMER SITE, CHECKED THE INJECTOR, AND VERIFIED OPERATION ACCORDING TO OPTIVANTAGE DUAL-HEAD CT CONTRAST DELIVERY SYSTEM V-5 AND ABOVE TEST AND INSPECTION DATA CHECKLIST 846130. THE INJECTOR WAS FULLY FUNCTIONAL, AND THE SYSTEM WAS WORKING PROPERLY. ALL PRESSURE TESTS PASSED. FSE ALSO SPOKE WITH TWO TECHNICIANS WHO SAID THEY HAVE HAD NO ISSUES WITH THE INJECTOR. INFILTRATIONS ARE GENERALLY CAUSED BY OPERATOR ERROR OR SIMILAR ISSUES. AS THE INJECTOR WAS CONFIRMED TO BE FULLY FUNCTIONAL AND WORKING AS INTENDED, THIS IS THE MOST LIKELY CAUSE FOR THIS COMPLAINT CONDITION. THIS IS EVEN MORE LIKELY AS THE CUSTOMER STATED THAT THE PATENCY CHECK FUNCTION OF THE INJECTOR IS NOT USED AT THIS TIME. A REVIEW OF GUERBET'S COMPLAINT TRACKING SYSTEM SHOWS A SERVICE CALL TO THIS SAME INJECTOR IN JULY WHERE THE SAME CT TECH WAS REPORTING THAT HE BELIEVED THE INJECTOR WAS PRESSURE LIMITING AT 200 PSI WHICH WOULD BE OUT OF SPECIFICATION AND WANTED A SERVICE CHECK ON THE INJECTOR. FSE WENT ON SITE, FOUND PRESSURES FUNCTIONING WITHIN SPECIFICATION, BUT DECIDED TO RECALIBRATE PRESSURES TO SATISFY THE TECHNICIAN. IMPACT ASSESSMENT SUMMARY: IMDRF CODES:B13, B01; C19; D14: E0504 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 RETURNED TO SERVICE.

    Description of Event or Problem · 0

    THIS INCIDENT WAS REPORTED BY A FACILITY IN (B)(6) ON (B)(6) 2023. THE REPORTER STATED THAT INFILTRATION OCCURRED ON 2 PATIENTS WHILE CONNECTED TO THE OPTIVANTAGE INJECTOR. AFTER FURTHER CONTACT WITH THE CUSTOMER, INFILTRATION WAS CONFIRMED. AN UNKNOWN CONTRAST AGENT WAS USED IN BOTH CASES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1112730 INJECTOR OPVSU NPS INJECTOR OPVSU NPS IZQ LIEBEL-FLARSHEIM 849002

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown