BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIVANTAGE DH

    MDR report key: 20880017 · Received December 9, 2024

    Report

    Report Number
    1518293-2024-00023
    Event Type
    Injury
    Date Received
    December 9, 2024
    Date of Event
    November 13, 2024
    Report Date
    December 9, 2024
    Manufacturer
    LIEBEL-FLARSHEIM
    Product Code
    DXT
    PMA / PMN Number
    K042744
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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 A PATIENT AIR INJECTION AND A REQUEST BY THE CUSTOMER FOR A REVIEW OF THE INJECTOR TO ENSURE THAT INJECTOR WAS OPERATING PROPERLY. GUERBET SERVICE SENT A SERVICE ENGINEER TO CHECK THE INJECTOR. THE SERVICE ENGINEER EVALUATED THE INJECTOR ACCORDING TO THE SERVICE CHECKLIST AND FOUND THE UNIT OPERATING NORMALLY. AFTER THE PERFORMANCE EVALUATION, THE EQUIPMENT WAS RELEASED BACK TO CUSTOMER USE. SERVICE ENGINEER REPORTED THAT THE PROBABLE CAUSE OF THE AIR INJECTOR WAS OPERATIONAL AND INSTRUCTED THE CUSTOMER ABOUT THE NEED TO REMOVE AIR FROM THE ENTIRE SYSTEM BEFORE PERFORMING THE INJECTION (THIS INFORMATION IS PROVIDED IN ALL TRAINING SESSIONS). 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. AN OPERATIONAL TRAINING SESSION ON THE INJECTOR WAS HELD FOR THE STAFF THAT WAS PRESENT. THE INJECTOR WAS RELEASED FOR USE. A REVIEW OF CTS SHOWS NO SIMILAR ISSUE PREVIOUSLY REPORTED ON THIS UNIT. IMPACT ASSESSMENT SUMMARY: THERE WERE IMMEDIATE COMPLAINTS OF DYSPNEA AND COUGHING, THEN AFTER MEDICATION INTERVENTION, THE PATIENT SHOWED IMPROVEMENT AND WAS DISCHARGED WITHOUT FURTHER COMPLAINTS OR ISSUE. 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 WAS 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 REMAINED IN SERVICE.

    Description of Event or Problem · 0

    THIS CASE WAS REPORTED BY A FACILITY IN (B)(6), BRAZIL ON (B)(6) 2024. CUSTOMER STATES THAT ON (B)(6) 2024 THAT AFTER THE INJECTION OF 86 ML OF CONTRAST, AIR WAS INJECTED, WHICH WAS VERIFIED BY THE DOCTOR IN THE IMAGES. THE PATIENT EXPERIENCED RESPIRATORY DISTRESS AND COUGHING, IMMEDIATELY AFTER THE INJECTION, THE PATIENT REMAINED IN THE UNIT FOR 40 MINUTES, A CONTROL CT SCAN OF THE CHEST AND SKULL WAS PERFORMED, WHICH NO LONGER SHOWED THE PRESENCE OF AIR AND CONTINUED WITH COMPLETE IMPROVEMENT OF THE SYMPTOMS. IT WAS IDENTIFIED THAT THE GUERBET SYRINGES, BOTH THE CONTRAST AND THE SALINE SYRINGES, WERE BENT AT THE TIME OF INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332664 OPTIVANTAGE DH OPTIVANTAGE DH DXT LIEBEL-FLARSHEIM 844001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other