BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIVANTAGE DH

    MDR report key: 20621429 · Received November 6, 2024

    Report

    Report Number
    1518293-2024-00017
    Event Type
    Injury
    Date Received
    November 6, 2024
    Report Date
    November 6, 2024
    Manufacturer
    LIEBEL-FLARSHEIM
    Product Code
    DXT
    PMA / PMN Number
    K042744
    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 AN OPTIVANTAGE INJECTOR 844001 SERIAL NUMBER (B)(6) ALLEGING AN AIR EMBOLISM OF NUMEROUS AIR BUBBLES IN THE HEART AFTER A PROCEDURE. ADDITIONAL INFORMATION WAS OBTAINED STATING THAT THE PATIENT WAS RELEASED WITHOUT ADVERSE EFFECT. CUSTOMER REPORTED THAT THE INJECTOR WAS NOT AT FAULT FOR THE AIR EMBOLISM STATING THAT A CONTRIBUTING FACTOR WAS THE MISUSE OF THE COSINE NACL BAGS. THE CODAN MICRO SPIKE BEING UTILIZED BY THE CUSTOMER IN CONJUNCTION WITH THESE NONSELF- SEALING BAGS AND THE 800096S BOON SYRINGE COULD ALSO HAVE PROMOTED AIR INTAKE DUE TO FIT ISSUES. 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. THE INJECTOR REMAINED IN SERVICE. A REVIEW OF GUERBET'S COMPLAINT TRACKING SYSTEM SHOWS NO RELATED COMPLAINT ACTIVITY FOR THIS DEVICE. IMPACT ASSESSMENT SUMMARY NO LONG TERM INJURY TO THE PATIENT REPORTED. IMDRF CODES: B13; C23; D20, D11. ROOT / PROBABLE CAUSE CODE: PROCESS/METHODS - INADEQUATE/INCORRECT PROCEDURE. ROOT / PROBABLE CAUSE SUMMARY: PROBABLE ROOT CAUSE WAS OPERATOR ERROR IN PURGING AIR FROM THE SYSTEM. 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), FRANCE ON 07 OCTOBER 2024. CUSTOMER STATES THAT AFTER PERFORMING THE CORONA SCANNER WITH OPTIJECT INJECTION, THE CARDIOLOGIST AND THE RADIOLOGIST WARN THE TECHNICIANS OF THE PRESENCE OF NUMEROUS AIR BUBBLES IN THE HEART CHAMBERS: AIR EMBOLISM. AIR EMBOLISM WITHOUT CLINICAL SYMPTOMS. HYPERBARIC CHAMBER SESSION ON (B)(6) 2024 RETURN TO THE PATIENT'S HOME (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1417557 OPTIVANTAGE DH OPTIVANTAGE DH DXT LIEBEL-FLARSHEIM 844001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown