BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INJ, OPTIV, MULT

    MDR report key: 20845010 · Received December 4, 2024

    Report

    Report Number
    1518293-2024-00021
    Event Type
    Injury
    Date Received
    December 4, 2024
    Date of Event
    November 7, 2024
    Report Date
    December 4, 2024
    Manufacturer
    LIEBEL-FLARSHEIM
    Product Code
    IZQ
    UDI-DI
    10746190002840
    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: (B)(6) SERVICE RECEIVED CUSTOMER REPORT OF A PATIENT AIR INJECTION USING OPTIVANTAGE INJECTOR 844009 SN (B)(6). (B)(6) SERVICE SENT A SERVICE ENGINEER ON SITE TO CHECK THE INJECTOR. THE SERVICE ENGINEER EVALUATED THE INJECTOR ACCORDING TO THE SERVICE CHECKLIST AND DETERMINED THE UNIT WAS OPERATING NORMALLY. THE INJECTOR WAS RETURNED TO CUSTOMER USE. 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 DISPLAYS A PROMPT REQUIRING THE OPERATOR TO CONFIRM 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. A REVIEW OF CTS SHOWS NO SIMILAR ISSUE PREVIOUSLY REPORTED ON THIS UNIT. IMPACT ASSESSMENT SUMMARY: PATIENT WAS DISCHARGED FROM INTENSIVE CARE UNIT AT THE (B)(6) HOSPITAL, AND IS IN CARDIOLOGY IN A STABLE CONDITION IMDRF CODES: B01; C23; D11. ROOT / PROBABLE CAUSE CODE. PERSONNEL - TRAINING - INADEQUATE. ROOT / PROBABLE CAUSE SUMMARY: SEE FAILURE MODES (NO PROBLEM/FAULT FOUND; INJECTOR OPERATION VERIFIED). PROBABLE ROOT CAUSE OPERATOR ERROR IN PURGING AIR FROM SYRINGE AND/OR TUBING. 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 FRANCE ON (B)(6) 2024. CUSTOMER STATES THAT AN AIR INJECTION WAS GIVEN TO A PATIENT. THE TEAM DIDN'T UNDERSTAND BECAUSE THE CONTRAST SYRINGE HADN'T FILLED UP WITH PRODUCT, EVEN THOUGH THERE WAS PRODUCT IN THE INFUSER. THE PATIENT WAS TREATED BY THE (B)(6) EMERGENCY DEPARTMENT. THE PATIENT HAS BEEN DYSPNOEIC SINCE HIS ARRIVAL. AFTER CHECKING THE INJECTION SYSTEM, THE TEAM NOTICED THAT THE SYRINGE CONTAINING THE PDC CONTRAST AGENT WAS EMPTY OF AIR, WHILE THE INFUSION CHAMBER HAD BEEN EMPTIED. THERE WAS CONTRAST MEDIUM IN THE INFUSION CHAMBER. AIR (90CC) HAD BEEN INJECTED INTO THE PATIENT. IMMEDIATE MEASURES TAKEN: THE PATIENT WAS PUT ON OXYGEN AND A CALL WAS MADE TO THE EMERGENCY DEPARTMENT AND A CARDIOLOGIST. THE PATIENT WAS TREATED AT THE (B)(6) EMERGENCY DEPARTMENT. THEN INFORMATION TO THE COMPANY (B)(6) FOR MATERIOVIGILANCE. ADDITIONAL COMMENTS: (B)(6) 2024 13:20: PATIENT CRITICAL OF HIS GENERAL CONDITION ON ARRIVAL WITH PARAMEDICS. INCOMPREHENSION OF THE PHENOMENON OF SYRINGE EMPTY OF AIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2108807 INJ, OPTIV, MULT INJ, OPTIV, MULT IZQ LIEBEL-FLARSHEIM 844009 10746190002840

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male Other