BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INJ. OPTIV DH,SI W/OEM

    MDR report key: 23351267 · Received October 21, 2025

    Report

    Report Number
    1518293-2025-00016
    Event Type
    Injury
    Date Received
    October 21, 2025
    Report Date
    October 21, 2025
    Manufacturer
    LIEBEL-FLARSHEIM
    Product Code
    IZQ
    UDI-DI
    10746190002710
    PMA / PMN Number
    K063503
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 AIR BUBBLES IN THE INJECTOR RESULTING IN A PATIENT EVACUATION. A SCAN WAS CONDUCTED AND FOUND AIR BUBBLES IN THE PULMONARY ARTERIES. THE PATIENT WAS HOSPITALIZED FOR TWO DAYS AND RECEIVED HYPERBARIC CHAMBER TREATMENT BEFORE FULLY RECOVERING WITHOUT LASTING EFFECTS. AIR INJECTIONS ARE GENERALLY NOT RELATED TO THE INJECTOR BUT ARE GENERALLY USER RELATED CAUSES. 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 SERVICE ENGINEER WENT ON SITE TO CHECK THE INJECTOR. SERVICE CLEANED CONTRAST FROM THE UNIT, CHECKED SIDE A AND B PRESSURE AND SIDE A AND B VOLUME WITH NO ISSUE NOTED. THE INJECTOR WAS TESTED FOR PROPER OPERATION AND FOUND TO BE FULLY FUNCTIONAL. UNIT REMAINED IN CUSTOMER USE. A REVIEW OF GUERBET COMPLAINT TRACKING SYSTEM (CTS) SHOWED NO RELATED COMPLAINT ACTIVITY FOR THIS DEVICE. IMPACT ASSESSMENT SUMMARY: PATIENT WAS HOSPITALIZED FOR TWO (2) DAYS BUT RECOVERED WITH NO ADDITIONAL ADVERSE EFFECTS. IMDRF CODES: B13; C23; D1101. ROOT / PROBABLE CAUSE CODE. PERSONNEL - PERFORMANCE - FAILED TO FOLLOW PROCEDURE. ROOT / PROBABLE CAUSE SUMMARY: SEE INVESTIGATION SUMMARY FOR DETAILS. AIR INJECTIONS ARE GENERALLY USER RELATED. THERE IS NO NEED FOR A CAPA AT THIS TIME. THESE ISSUES ARE REPORTED UPON DURING PERIODIC QUALITY REVIEWS TO CONSIDER INPUT FOR CORRECTIVE ACTION. QA WILL CONTINUE TO MONITOR AND TREND FOR SIMILAR ISSUES. DISPOSITION SUMMARY: UNIT REMAINED IN USE.

    Description of Event or Problem · 0

    THIS CASE WAS REPORTED BY A FACILITY IN PARIS, FRANCE ON (B)(6) 2025. CUSTOMER REPORTED THAT THEY WERE INFORMED BY OTHER INDIVIDUALS THAT DURING THE PRIVATE FRIDAY MORNING SESSION AT THE (B)(6), A PATIENT HAD TO BE EVACUATED DUE TO BUBBLES IN THE OPTIVANTAGE INJECTOR. THE PATIENT UNDERWENT A CONTRAST-ENHANCED CT SCAN OF THE ENT AREA. THE SCAN REVEALED AIR BUBBLES IN THE PULMONARY ARTERIES, AS OBSERVED BY THE DOCTOR. THE PATIENT WAS TRANSFERRED TO (B)(6) HOSPITAL AND HOSPITALIZED FOR TWO DAYS. HE RECEIVED HYPERBARIC CHAMBER TREATMENT AND FULLY RECOVERED WITHOUT ANY LASTING EFFECTS FROM THE INCIDENT. THE PURGE WAS PERFORMED AND CONFIRMED BY THE RADIOLOGY TECHNICIAN TO THE DOCTOR AT THE TIME OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1905399 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 Other