BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INJECTOR, OPTIVANTAGE DH W/RFID

    MDR report key: 18021210 · Received October 27, 2023

    Report

    Report Number
    1518293-2023-00030
    Event Type
    Malfunction
    Date Received
    October 27, 2023
    Report Date
    October 5, 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

    OVERALL INVESTIGATION SUMMARY: A COMPLAINT WAS RECEIVED ON OPTIVANTAGE INJECTOR 844003 SERIAL NUMBER (B)(6) ALLEGING THE INJECTOR WAS INJECTING WITHOUT COMMAND FROM THE OPERATOR AND WAS ALSO STOPPING IN THE MIDDLE OF PROCEDURES. WHILE THIS CONDITION OCCURRED WITH A PATIENT CONNECTED, IT WAS REPORTED THERE WAS NO HARM TO THE PATIENT. SERVICE ENGINEER RAN TESTS AND SIMULATIONS ON THE ALLEGED DEFECT AND FOUND THAT THE LIKELY CAUSE WAS THE COMPLETE OXIDATION OF THE COMMUNICATION CABLE (PN 800110) AND POWER HEAD CABLE (PN 844378S) AS CAN BE SEEN IN THE ATTACHED PICTURES. THE PINS WERE BROKEN/DAMAGED DUE TO OXIDATION. SERVICE ENGINEER REPLACED THE CABLES, VERIFIED THE SYSTEM EXHIBITED PROPER FUNCTION, AND RETURNED THE UNIT TO SERVICE. 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; C17; D07. ROOT / PROBABLE CAUSE CODE. EQUIPMENT/INSTRUMENT - FAILURE. ROOT / PROBABLE CAUSE SUMMARY: REFER TO INVESTIGATION 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 RETURNED TO CUSTOMER USE.

    Description of Event or Problem · 0

    THIS INCIDENT WAS REPORTED BY A FACILITY IN (B)(6), BRAZIL ON (B)(6) 2023. REPORTER INFORMED THAT "I REQUEST AN URGENCY CALL FOR A CONTRAST INJECTOR THAT IS HAVING A PROBLEM INJECTING WITHOUT THE OPERATOR GIVING THE COMMAND AND IS STOPPING INJECTING IN THE MIDDLE OF THE PROCEDURE. DIODE CONTRAST WAS USED, THE EQUIPMENT WAS CONNECTED TO THE PATIENT AND THE PROCEDURE WAS NOT COMPLETED. TH REPORTER ALSO STATED THAT THERE WERE NO INJURIES REPORTED TO PATIENT OR STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1151424 INJECTOR, OPTIVANTAGE DH W/RFID INJECTOR, OPTIVANTAGE DH W/RFID IZQ LIEBEL-FLARSHEIM 844003

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown