BEUDAMED
    FDA Adverse Event Death Summary report: N

    INJECTOR OPVSU NPS

    MDR report key: 21753096 · Received April 2, 2025

    Report

    Report Number
    1518293-2025-00008
    Event Type
    Death
    Date Received
    April 2, 2025
    Report Date
    April 2, 2025
    Manufacturer
    LIEBEL- FLARSHEIM
    Product Code
    IZQ
    UDI-DI
    10746190002925
    PMA / PMN Number
    K063503
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OVERALL INVESTIGATION SUMMARY: GUERBET WAS CONTACTED BY A CUSTOMER REPORTING A FATAL AIR BOLUS OCCURRED USING OPTIVANTAGE INJECTOR 849002 SERIAL NUMBER (B)(6). THE CUSTOMER DID NOT BLAME THE INJECTOR AND CONSIDERS THIS A TECHNOLOGIST ERROR. ADDITIONAL DETAILS WERE REQUESTED FROM THE CUSTOMER BUT HAVE NOT BEEN RECEIVED AT THE TIME OF COMPLAINT INVESTIGATION CLOSURE. THIS COMPLAINT WILL BE REOPENED WHEN THE ADDITIONAL DETAILS ARE RECEIVED. THERE WAS NO REPORT OF MALFUNCTION OR REQUEST FOR EVALUATION OF THE INJECTOR; THEREFORE, THE INVESTIGATION REVIEWED HISTORICAL RECORDS AND DESIGN RECORDS. OPTIVANTAGE WAS NOT DESIGNED AND IS NOT CAPABLE OF DETECTING OR PREVENTING AIR INJECTIONS; HOWEVER, AS LISTED BELOW, 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. HISTORICAL COMPLAINTS FOR OPTIVANTAGE AIR INJECTIONS WERE REVIEWED AND ALL INSTANCES WERE DETERMINED TO BE USER-RELATED, INDEPENDENT OF THE INJECTOR. THE RISK ASSESSMENT AND CONTROL DOCUMENTATION FOR THE OPTIVANTAGE WAS REVIEWED AND CONFIRMED THAT THE HAZARDOUS SITUATION OF AIR INJECTIONS LEADING TO AIR EMBOLISMS HAVE BEEN MITIGATED WITHIN THE MANUFACTURER'S CAPACITY. THE MITIGATIONS IN PLACE INCLUDE, BUT ARE NOT LIMITED TO WARNING STATEMENTS IN THE INSTRUCTIONS FOR USE (IFU), SYRINGE ADAPTERS PROVIDING A CLEAR VIEW OF THE SYRINGE, PROMPTS APPEARING ON SCREEN TO ENSURE THE USER FOLLOWS A PROPER FILL/PURGE SEQUENCE ON THE SYRINGES, A "CHECK FOR AIR..." MESSAGE ON THE POWERHEAD AND CONSOLE DISPLAYS, AND THE IFU CONTAINING INSTRUCTIONS ON HOW TO CLEAR AIR BUBBLES FROM THE CONSUMABLES. A REVIEW OF GUERBET'S COMPLAINT TRACKING SYSTEM RELATED TO THIS UNIT WAS CONDUCTED BUT FOUND NO RELATED INCIDENTS. GUERBET TECHNICAL SERVICE TEAM HAS NEVER SERVICED THIS INJECTOR OUTSIDE OF THE INITIAL INSTALLATION AND APPLICATIONS TRAINING. THE HEALTH HAZARD EVALUATION (HHE) (B4) WAS OPENED IN RELATION TO THIS COMPLAINT. THE HHE CONCLUSION INDICATES NO ACTIONS ARE WARRANTED AT THIS TIME. IMPACT ASSESSMENT SUMMARY: THE AIR BOLUS WAS FATAL AND THE PATIENT PASSED. IMDRF CODES = B13, B11; C19, C23; D11. ROOT/PROBABLE CAUSE CODE: PERSONNEL - PERFORMANCE - FAILED TO FOLLOW PROCEDURE. ROOT/ PROBABLE CAUSE SUMMARY: AIR INJECTIONS ARE GENERALLY USER-RELATED AS THE OPTIVANTAGE INJECTOR REQUIRES THE USERS TO MANUALLY PURGE THE AIR FROM THE SYSTEM AND CONFIRM THAT THEY HAVE CHECKED FOR AIR. BASED ON THIS AND THE INVESTIGATION, THERE IS NO NEED FOR A CAPA AT THIS TIME. COMPLAINTS ARE TRENDED AND REPORTED DURING MANAGEMENT AND METRIC REVIEWS TO CONSIDER CORRECTIVE ACTION. QUALITY WILL CONTINUE TO MONITOR AND TREND FOR SIMILAR ISSUES. DISPOSITION SUMMARY: THE UNIT REMAINED IN USE.

    Description of Event or Problem · 0

    THIS INCIDENT WAS REPORTED BY A FACILITY IN (B)(6) ON (B)(6) 2025. "(B)(6) 2025, GUERBET WAS CONTACTED (B)(6) ASKING FOR DOCUMENTATION OF TRAINING FOR THE STAFF ON (B)(6) 2021. SHE REPORTED A FATAL AIR BOLUS USING THE OPTIVANTAGE, SHE DOES NOT BLAME THE INJECTOR BUT CONSIDERS THIS TECHNOLOGY ERROR WHO HAS BEEN USING THE INJECTOR SINCE INSTALL IN 2021. THEY USE GUERBET SELF FILL SYRINGES.".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744720 INJECTOR OPVSU NPS INJECTOR OPVSU NPS IZQ LIEBEL- FLARSHEIM 849002 10746190002925

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death