BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INJ, OPTIV, MULI

    MDR report key: 16385352 · Received February 16, 2023

    Report

    Report Number
    1518293-2023-00001
    Event Type
    Malfunction
    Date Received
    February 16, 2023
    Report Date
    January 19, 2023
    Manufacturer
    LIEBEL-FLARSHEIM
    Product Code
    IZQ
    PMA / PMN Number
    K063503
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REGIONAL SERVICE COMPLETED AN INSPECTION OF THE EQUIPMENT AND THE REPORTED ISSUE WAS NOT SEEN. ALL THE FUNCTIONAL TESTS WERE CARRIED OUT ACCORDING TO THE INJECTOR'S SERVICE CHECKLIST AND EVERYTHING WAS NORMAL. IT APPEARS THAT THE STAFF DID NOT KNOW HOW TO HANDLE THE EQUIPMENT, AND DID NOT KNOW HOW TO REMOVE THE AIR FROM THE DISPOSABLES. SERVICE PROVIDED GUIDANCE FOR CORRECT OPERATION AND ADVISED ADDITIONAL OPERATIONAL TRAINING. THE EQUIPMENT WAS OPERATING NORMALLY AND FULLY FUNCTIONAL. A REVIEW OF CTS SHOWS NO SIMILAR ISSUE REPORTED ON THIS UNIT. A REVIEW OF GUERBET COMPLAINT TRACKING SYSTEM (CTS) SHOWED NO RELATED COMPLAINT ACTIVITY FOR THIS DEVICE. IMPACT ASSESSMENT SUMMARY: NO INJURY TO THE PATIENT/USER REPORTED. IMDRF CODES: B01; C23; D11. PROCESS/METHODS: INADEQUATE/INCORRECT PROCEDURE. ROOT / PROBABLE CAUSE 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 FULL SERVICE.

    Description of Event or Problem · 0

    THIS INCIDENT WAS REPORTED BY A FACILITY IN (B)(6), BRAZIL ON 19 JANUARY 2023. THE REPORTER INFORMED THAT AIR BUBBLES ARE ENTERING DURING THE INJECTION OF CONTRAST MEDIA. THERE WAS NO INJURY TO PATIENT. PROCEDURE WAS NOT CONCLUDED. THEY DON´T KNOW THE CONTRAST MEDIA USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385589 INJ, OPTIV, MULI INJ, OPTIV, MULI IZQ LIEBEL-FLARSHEIM 844008 C0521B687G

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown