BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIVANTAGE DH

    MDR report key: 21586177 · Received March 12, 2025

    Report

    Report Number
    1518293-2025-00003
    Event Type
    Injury
    Date Received
    March 12, 2025
    Date of Event
    February 5, 2025
    Report Date
    March 12, 2025
    Manufacturer
    LIEBEL-FLARSHEIM
    Product Code
    IZQ
    PMA / PMN Number
    K063503
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OVERALL INVESTIGATION SUMMARY: A COMPLAINT WAS RECEIVED ON OPTIVANTAGE INJECTOR 844001 SERIAL NUMBER (B)(6) ALLEGING THAT AIR WAS INTRODUCED INTO A PATIENT'S VASCULAR SYSTEM DURING AN INJECTION ON (B)(6) 2025. GUERBET SERVICE WAS ASKED TO CHECK THE INJECTOR FOR OPERATION. SERVICE WAS DISPATCHED TO THE CUSTOMER SITE, CHECKED THE INJECTOR'S OPERATION, AND DETERMINED THAT THE INJECTOR WAS FULLY FUNCTIONAL AND THAT IT WAS GIVING THE NECESSARY WARNINGS FOR CORRECT PURGING AND CHECKING FOR THE PRESENCE OF AIR. THE INJECTOR REMAINED IN SERVICE. THERE WAS NO REPORT OF ANY LONG-TERM PATIENT RELATED ISSUE. THE OPTIVANTAGE IS NOT EQUIPPED WITH AIR DETECTORS; HOWEVER, THE IFU INCLUDES INSTRUCTIONS FOR THE PROPER PURGING OF AIR FROM THE SYSTEM PRIOR TO INJECTION, AS WELL AS PRECAUTIONS AND STEPS TO PREVENT AIR INJECTIONS. ADDITIONALLY, THE OPTIVANTAGE SENDS A PROMPT TO THE OPERATOR REQUIRING THE OPERATOR TO ENSURE ALL AIR IS PURGED FROM THE SYSTEM AND ASSOCIATED CONSUMABLES PRIOR TO THE INJECTION. THE OPERATOR MUST PRESS THE SCREEN ACKNOWLEDGING THIS HAS BEEN COMPLETED PRIOR TO THE DEVICE ENABLING THE INJECTION. FOR THESE REASONS, AIR INJECTIONS ARE GENERALLY USER RELATED. A REVIEW OF GUERBET'S COMPLAINT TRACKING SYSTEM SHOWS NO RELATED COMPLAINT ACTIVITY FOR THIS DEVICE. IMPACT ASSESSMENT SUMMARY: AIR INJECTED INTO PATIENT BUT NO LONG TERM INJURY REPORTED. IMDRF CODES: B01; C19: D1101. ROOT / PROBABLE CAUSE CODE. PERSONNEL - PERFORMANCE - FAILED TO FOLLOW: PROCEDURE. ROOT / PROBABLE CAUSE SUMMARY: FAILURE MODES (NO PROBLEM/FAULT FOUND, INJECTOR OPERATION VERIFIED). PROBABLE ROOT CAUSE IS OPERATOR ERROR IN PURGING AIR FROM SYRINGE AND/OR TUBING (REF. IFU, 848581-C, SECTION 4.1). NO FURTHER INVESTIGATION NEEDED AT THIS TIME. QA WILL CONTINUE TO MONITOR AND TREND FOR SIMILAR ISSUES. NO CAPA AT THIS TIME, THESE TRENDS AND ISSUES ARE REPORTED ON DURING QUALITY METRICS REVIEWS AND DURING THE MANAGEMENT REVIEW MEETINGS TO CONSIDER INPUT FOR CORRECTIVE ACTION. DISPOSITION SUMMARY: UNIT RETURNED TO SERVICE.

    Description of Event or Problem · 0

    THIS CASE WAS REPORTED BY A FACILITY IN MADRID, SPAIN ON 13 FEBRUARY 2025. CUSTOMER REPORTS THAT AIR WAS INTRODUCED INTO THE VASCULAR SYSTEM OF A PATIENT DURING AN INJECTION ON (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1560135 OPTIVANTAGE DH OPTIVANTAGE DH IZQ LIEBEL-FLARSHEIM 844001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other