BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INJ. OPTIV DH,SI W/OEM

    MDR report key: 21654029 · Received March 20, 2025

    Report

    Report Number
    1518293-2025-00005
    Event Type
    Malfunction
    Date Received
    March 20, 2025
    Report Date
    March 20, 2025
    Manufacturer
    LIEBEL- FLARSHEIM
    Product Code
    IZQ
    UDI-DI
    10746190002710
    PMA / PMN Number
    K063503
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OVERALL INVESTIGATION SUMMARY A COMPLAINT WAS RECEIVED ON OPTIVANTAGE INJECTOR 844005 SERIAL NUMBER (B)(6) ALLEGING EIGHT (8) SEPARATE EXTRAVASATIONS AND REQUESTED AN EVALUATION OF THE EQUIPMENT. THE SERVICE ENGINEER COMPLETED AN INSPECTION OF THE INJECTOR, CONDUCTED PERFORMANCE TESTS ACCORDING TO PROTOCOL, AND VERIFIED FLOW RATE & PRESSURE LIMITS WERE ALL WITHIN PERMITTED RANGE. SERVICE STATED THE REPORTED PROBLEM WAS ATTRIBUTABLE TO BAD CONNECTION TO PATIENT. NO PRESSURE PROBLEMS FOUND. EQUIPMENT IS OPERATIONAL. THE TECHNICIAN WHO HANDLED THE CASE INFORMED THE GUERBET PHARMACOVIGILANCE ANALYST THAT THE EQUIPMENT DID NOT PRESENT ANY ERRORS AND IT SEEMED THAT THE EXTRAVASATION WAS DUE TO OPERATIONAL ERROR. THE TECHNICIAN ALSO STATED THAT AN EXTRAVASATION ALSO OCCURRED MORE THAN ONCE I.N ANOTHER INJECTOR THAT IS NOT A GUERBET PRODUCT, SUPPORTING THIS LIKELY ROOT CAUSE OF OPERATOR BASED. THE OPTIVANTAGE 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. ADDITIONALLY, DESCRIBED IN THE MANUAL ARE I.V. SITE PATENCY CHECK TECHNIQUES, INCLUDING A MANUAL METHOD AND ANOTHER USING A PATENCY KEY IN THE SETUP SCREEN. A REVIEW OF GUERBET COMPLAINT TRACKING SYSTEM (CTS) SHOWED NO RELATED COMPLAINT ACTIVITY FOR THIS DEVICE. IMPACT ASSESSMENT SUMMARY NO LONG TERM INJURY TO THE PATIENT 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 INCIDENT WAS REPORTED BY A FACILITY (B)(6), BRAZIL ON DATE FEBRUARY24, 2025. REPORTER INFORMED THAT "CONTRAST EXTRAVASATION. EIGHT INCIDENTS OF CONTRAST EXTRAVASATION WERE REPORTED IN FEBRUARY. THE ASSEMBLY OF THE CIRCUIT AND THE ENTIRE PROCESS UP TO THE PATIENT HAVE ALREADY BEEN CHECKED, AND IN VIEW OF THIS, WE REQUEST AN URGENT CHECK OF THE EQUIPMENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1306824 INJ. OPTIV DH,SI W/OEM INJ. OPTIV DH,SI W/OEM IZQ LIEBEL- FLARSHEIM 844005 10746190002710

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown