BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INJ. OPTIV DH, W/OEM

    MDR report key: 20522788 · Received October 24, 2024

    Report

    Report Number
    1518293-2024-00018
    Event Type
    Malfunction
    Date Received
    October 24, 2024
    Report Date
    October 24, 2024
    Manufacturer
    LIEBEL-FLARSHEIM
    Product Code
    IZQ
    UDI-DI
    10746190002727
    PMA / PMN Number
    K063503
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OVERALL INVESTIGATION SUMMARY: A COMPLAINT WAS RECEIVED ON OPTIVANTAGE INJECTOR 844007 SERIAL NUMBER (B)(6) ALLEGING AN EXTRAVASATION DUE TO THE INJECTOR PRESSURE NOT BEING ACCURATE. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THIS IS AN ISOLATED INCIDENT WHERE APPROXIMATELY 2ML OF AN UNSPECIFIED CONTRAST AGENT WAS EXTRAVASATED INTO THE PATIENT'S TISSUE, CAUSING SWELLING AND PAIN. THE PATIENT WAS LATER DISCHARGED WITH NO ADVERSE REACTIONS. REGIONAL SERVICE ENGINEER EVALUATED THE INJECTOR, CONDUCTING VERIFICATION TESTS ON FLOW RATE AND PRESSURE LIMITS. IT WAS DETERMINED THAT THE INJECTOR WAS FULLY OPERATIONAL AND WAS NOT THE CAUSE OF THE EXTRAVASATION. THE INJECTOR WAS THEN RETURNED TO CUSTOMER USE. REGIONAL SERVICE SUGGESTS THAT THE CAUSE WAS THE IMPROPER PLACEMENT OF THE NEEDLE. EXTRAVASATIONS ARE GENERALLY CAUSED BY THE OPERATOR. THE INJECTOR DOES NOT HAVE THE CAPABILITY TO DETECT NOR PREVENT AN EXTRAVASATION; HOWEVER, PRECAUTIONS TO MINIMIZE THE LIKELIHOOD OF AN EXTRAVASATION ARE PROVIDED IN THE INSTRUCTIONS FOR USE. ADDITIONALLY, THE OPTIVANTAGE IFU DESCRIBES PATENCY CHECK TECHNIQUES. A REVIEW OF GUERBET'S COMPLAINT TRACKING SYSTEM SHOWS NO RELATED COMPLAINT ACTIVITY ON THIS UNIT. IMPACT ASSESSMENT SUMMARY: NO SERIOUS OR LONG TERM INJURY TO THE PATIENT REPORTED IMDRF CODES: B01; C23; D20, D11. ROOT / PROBABLE CAUSE CODE: PROCESS/METHODS - INADEQUATE/INCORRECT PROCEDURE. ROOT / PROBABLE CAUSE SUMMARY: REFER TO INVESTIGATION SUMMARY. NO DEFECT/MALFUNCTION OF INJECTOR. 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 RELEASED FOR USE.

    Description of Event or Problem · 0

    THIS CASE WAS REPORTED BY A FACILITY IN (B)(6) CHINA ON 25 SEPTEMBER 2024. DETAILS OF THE CASE ARE AS DESCRIBED BELOW: SETTING NAME: (B)(6). PRODUCT NAME: HIGH PRESSURE INJECTOR (OPTIVANTAGE DH) INJURY: SERIOUS INJURY MANIFESTATIONS: DRUG EXTRAVASATION, LOCAL SUBCUTANEOUS EDEMA AT THE INDWELLING NEEDLE LOCATION, AND OBVIOUS PAIN. INSTRUMENT FAILURE: HIGH PRESSURE INJECTOR PRESSURE IS NOT ACCURATE USE PROCESS: ON (B)(6) 2024, THE PATIENT UNDERWENT CTA IN THE ARTERIES OF BOTH LOWER LIMBS. THE RADIOLOGY NURSE FIRST CONDUCTED TWO UNBLOCKAGE TESTS, EACH WITH A VOLUME OF 5ML NORMAL SALINE AND A SPEED OF 4ML/S. THE PATIENT HAD NO LOCAL SWELLING WITH THE RETENTION NEEDLE AND NO SELF-REPORTED PAIN AND DISCOMFORT. NORMAL SCANNING AND INJECTION OF CONTRAST AGENT BEGAN AFTER THE END OF THE EXPERIMENT. WHEN THE SCAN WAS NEARLY HALF OVER, THE MACHINE ISSUED A HIGH PRESSURE ALARM, PROMPTING THE INJECTION TO CONTINUE OR STOP. AT THIS TIME, THE OPERATOR FOUND THAT ALMOST ALL THE INJECTION OF CONTRAST AGENT HAD BEEN COMPLETED, AND THE SCAN WAS COMPLETED AFTER THE INJECTION WAS STOPPED. AFTER THE PATIENT RETURNED TO THE WARD, THE DOCTOR GAVE MAGNESIUM SULFATE WET COMPRESS AND ICE TREATMENT, AND ON (B)(6) 2024, THE PATIENT WAS DISCHARGED AFTER THE EXAMINATION FOUND THAT THE EDEMA HAD SUBSIDED AND THERE WERE NO ADVERSE REACTIONS. CAUSE ANALYSIS: UNABLE TO DETERMINE EVENT CAUSE ANALYSIS DESCRIPTION: THE DRUG EXTRAVASATION, THERE MAY BE THE PROBLEM OF INACCURATE PRESSURE OF HIGH PRESSURE INJECTOR. PRELIMINARY TREATMENT: NOTIFIED THE OPERATING ENTERPRISE, AND CONTACTED THE FACTORY ENGINEER, AGREED TO COME OVER FOR A DETAILED OVERHAUL OF THE MACHINE, AND LET THE DEVICE PRESSURE TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2565944 INJ. OPTIV DH, W/OEM INJ. OPTIV DH, W/OEM IZQ LIEBEL-FLARSHEIM 844007 10746190002727

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown