BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INJ. OPTIV DH, W/OEM

    MDR report key: 19069554 · Received April 9, 2024

    Report

    Report Number
    1518293-2024-00009
    Event Type
    Malfunction
    Date Received
    April 9, 2024
    Date of Event
    March 5, 2024
    Report Date
    April 9, 2024
    Manufacturer
    LIEBEL-FLARSHEIM
    Product Code
    IZQ
    PMA / PMN Number
    K063503
    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 A DELAYED TREATMENT DUE TO A BURST IN THE HIGH PRESSURE INJECTOR BASE, KNOWN AS THE FACEPLATE AND PRESSURE SLEEVE. WHILE THE INITIAL COMPLAINT REPORTED A SERIOUS INJURY, THERE WAS NO ACTUAL INJURY REPORTED. UPON REQUESTS FOR ADDITIONAL INFORMATION, THE COMPLAINANT STATED THAT THE PATIENT NEEDED PSYCHOLOGICAL COMFORT, LEADING TO THE REPORTABILITY DECISION. IT WAS CONFIRMED THAT THERE WERE NO INJURIES AND THAT THE PATIENT WAS FINE. DURING THE INVESTIGATION, GUERBET SERVICE WAS INFORMED OF A BROKEN B SIDE 200 ML PRESSURE SLEEVE WHICH WAS REPORTED TO HAVE OCCURRED DURING A PROCEDURE. THE INJECTOR THEN STOPPED, AND THE PATIENT WAS MOVED TO ANOTHER ROOM TO COMPLETE THE PROCEDURE. WHEN THE PRESSURE SLEEVE BROKE, THE FACILITY ENGINEER WAS CALLED AND REPLACED THE 200 ML FACEPLATE ASSEMBLY, (B)(4). AFTER THE REPLACEMENT OF FACEPLATE ASSEMBLY, WHICH INCLUDES THE PRESSURE SLEEVE (B)(4), THE INJECTOR WAS REPORTED TO BE OPERATING NORMALLY AND REMAINED IN USE. IT WAS ALSO NOTED BY SERVICE THAT THE CUSTOMER WAS USING SYRINGES NOT APPROVED FOR USE WITH THIS SYSTEM. THIS IS MOST LIKELY THE CAUSE OF THE BREAKAGE; HOWEVER, THE FACEPLATES ARE TO BE CHECKED DAILY AND REPLACED AS NEEDED PER THE FU OF THE INJECTOR AS THE FACEPLATE IS A KNOWN WEAR ITEM. A REVIEW OF GUERBET'S COMPLAINT TRACKING SYSTEM SHOWS AN ISSUE REPORTED ON THIS UNIT IN DECEMBER 2023 WHERE AN UNAPPROVED NON- GUERBET SYRINGE WAS REPORTED TO HAVE BROKEN DURING A PROCEDURE. IMPACT ASSESSMENT SUMMARY: NO INJURY TO THE PATIENT/USER REPORTED IMDRF CODES: B01; C07, C070603 C13; D15 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 SERVICE

    Description of Event or Problem · 0

    THIS CASE WAS REPORTED BY A FACILITY IN (B)(6) ON 13 MARCH 2024. INJURY: SERIOUS INJURY MANIFESTATION OF INJURY: DELAYED TREATMENT INSTRUMENT FAILURE MANIFESTATION: PRODUCT QUALITY PROBLEMS INTENDED TREATMENT DISEASE OR EFFECT: FOR THE TREATMENT OF CEREBRAL INFARCTION. USE PROCESS: ON (B)(6) 2024, THE PATIENT WAS HOSPITALIZED DUE TO CEREBRAL INFARCTION. BEFORE CT ENHANCEMENT SCAN, WHEN INJECTING CONTRAST AGENT, THE HIGH-PRESSURE INJECTOR SUDDENLY STOPPED WORKING DURING THE INJECTION PROCESS, AND THE CONTRAST AGENT INJECTION OPERATION WAS FORCED TO STOP. CLINICAL TECHNICIANS AND MEDICAL STAFF IMMEDIATELY TRANSFERRED THE PATIENT TO OTHER CT EQUIPMENT TO CONTINUE CT ENHANCEMENT SCAN. THE PATIENT'S CT ENHANCED SCAN WAS SUCCESSFULLY COMPLETED. THE MAINTENANCE PERSONNEL OF THE EQUIPMENT DEPARTMENT REPAIRED THE FAULTY EQUIPMENT, WHICH WAS CHECKED TO BE CAUSED BY THE BURST OF THE HIGH PRESSURE INJECTOR BASE. AFTER REPLACING THE HIGH PRESSURE INJECTOR BASE, THE FAULT WAS REMOVED AND THE EQUIPMENT RETURNED TO NORMAL.EVENT CAUSE ANALYSIS: PRODUCT CAUSE (INCLUDING INSTRUCTIONS, ETC.)INCIDENT CAUSE ANALYSIS DESCRIPTION: THE MAINTENANCE PERSONNEL OF THE EQUIPMENT DEPARTMENT REPAIRED THE FAULTY EQUIPMENT, AND IT WAS CHECKED THAT THE HIGH PRESSURE INJECTOR BASE BURST.PRELIMINARY TREATMENT: AFTER THE HIGH-PRESSURE INJECTOR BASE IS REPLACED, THE FAULT IS REMOVED AND THE EQUIPMENT RETURNS TO NORMAL.ADDITIONAL INFORMATION RECEIVED ON 15/MAR/2024: THEY ALSO SAID THAT THEY HAVE BOUGHT THE APPROPRIATE ACCESSORIES TO FIX THIS INJECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2270111 INJ. OPTIV DH, W/OEM INJ. OPTIV DH, W/OEM IZQ LIEBEL-FLARSHEIM 844007

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown