BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIVANTAGE DH

    MDR report key: 18587441 · Received January 26, 2024

    Report

    Report Number
    1518293-2024-00003
    Event Type
    Malfunction
    Date Received
    January 26, 2024
    Report Date
    January 3, 2024
    Manufacturer
    LIEBEL-FLARSHEIM
    Product Code
    IZQ
    PMA / PMN Number
    K063503
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OVERALL INVESTIGATION SUMMARY: A COMPLAINT WAS RECEIVED ON OPTIVANTAGE INJECTOR PN 844001 SN (B)(6) ALLEGING A SMALL AIR EMBOLISM ON ONE OF THE PATIENTS SCANS. THERE WAS NO PATIENT INJURY REPORTED. SINCE THEN, THE RADIOGRAPHERS INDICATED THAT THEY HAVE BEEN EXTRA CAUTIOUS WITH EXPELLING THE AIR FROM THE SYSTEM. HOWEVER, CUSTOMER HAD FOUR (4) SEPARATE RADIOGRAPHERS NOW SAY THEY HAVE EXPELLED ALL THE AIR FROM THE SYSTEM, AND THEN WHEN THEY HAVE GONE TO CONNECT THE PATIENT TO THE INJECTOR THEY HAVE NOTICED AIR IS BACK IN THE SYSTEM. CUSTOMER REPORTS THAT THE SYSTEM WORKS WITH PRE-FILLED SYRINGES AND FEELS THE ISSUE WAS A USER APPLICATION ISSUE. INSTRUCTIONS FOR THE PROPER PURGING OF AIR FROM THE SYSTEM PRIOR TO INJECTION, AS WELL AS PRECAUTIONS, ARE COVERED IN DETAIL IN THE INSTRUCTIONS FOR USE (REF. IFU, 848581, SECTION 4.1), INCLUDING STEPS TO PREVENT AIR INJECTIONS. ADDITIONALLY, THE OPTIVANTAGE INJECTOR SENDS A PROMPT TO THE OPERATOR REQUIRING THEM TO ENSURE ALL AIR IS PURGED FROM THE SYSTEM AND ASSOCIATED HARDWARE, PRIOR TO INJECTION. THE OPERATOR MUST PRESS A BUTTON ON THE INJECTOR ACKNOWLEDGING THIS HAS BEEN COMPLETED PRIOR TO THE DEVICE ENABLING THE INJECTION. THEREFORE, AIR INJECTIONS ARE TYPICALLY USER RELATED. THE COMPLAINT WILL BE CLOSED BASED UPON THE INFORMATION GUERBET CURRENTLY HAS. IF REQUESTED, ADDITIONAL TRAINING IS AVAILABLE ONSITE VIA AN APPLICATIONS SPECIALIST THAT CAN BE DISPATCHED AT THE END OF (B)(6) 2024 OR POSSIBLY REMOTE SUPPORT OVER THE PHONE. A REVIEW OF GUERBET COMPLAINT TRACKING SYSTEM SHOWED NO RELATED COMPLAINT ACTIVITY FOR THIS DEVICE. IMPACT ASSESSMENT SUMMARY: NO INJURY TO THE PATIENT/USER REPORTED IMDRF CODES: B13, B11; 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 CASE WAS REPORTED BY A FACILITY IN LONDON, UNITED KINGDOM ON (B)(6) 2024. REPORTER STATES WHILST USING THE MULTI-PHASE SYSTEM A SMALL AIR EMBOLI'S WAS NOTICED ON ONE OF OUR PATIENTS SCANS THIS MORNING. SINCE THEN THE RADIOGRAPHERS HAVE BEEN EXTRA CAUTIOUS WITH EXPELLING THE AIR FROM THE SYSTEM. HOWEVER, I HAVE HAD 4 SEPARATE RADIOGRAPHERS NOW SAY THEY HAVE EXPELLED ALL THE AIR FROM THE SYSTEM AND THEN WHEN THEY HAVE GONE TO CONNECT THE PATIENT TO THE INJECTOR THEY HAVE NOTICED AIR IS BACK IN THE SYSTEM. WE HAVE MOVED FROM THE MULTI USE SYSTEM TO USING SINGLE SYRINGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1316592 OPTIVANTAGE DH OPTIVANTAGE DH IZQ LIEBEL-FLARSHEIM 844001

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other