BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTISTAR ELITE NPS

    MDR report key: 12635777 · Received October 14, 2021

    Report

    Report Number
    1518293-2021-00030
    Event Type
    Malfunction
    Date Received
    October 14, 2021
    Date of Event
    September 17, 2021
    Report Date
    September 17, 2021
    Manufacturer
    LIEBEL-FLARSHEIM
    Product Code
    DXT
    PMA / PMN Number
    K073592
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OVERALL INVESTIGATION SUMMARY CUSTOMER REPORTED THAT THE INJECTOR HAS BEEN HITTING THE PRESSURE LIMIT HARD EXTENDING SHOT DURATION SINCE THE INJECTOR IS REDUCING THE FLOW RATE. CUSTOMER REQUESTED SERVICE TO VERIFY PRESSURES AND SEE IF THERE WERE ANY OTHER ISSUES. CUSTOMER ALSO REPORTED THAT THEY NOTED THE LEAK OF DOTAREM CONTRAST MEDIA AND NOTED THAT THIS OCCURRED ON TWO CASES: ON THE 1ST CASE, PATIENT DID NOT RECEIVE EXPECTED DOSE OF CONTRAST AND HAD TO DO A RESCAN. ON THE 2ND CASE, PATIENT RECEIVED ENOUGH TO COMPLETE THE SCAN. FIELD SERVICE ENGINEER (FSE) WENT ON SITE TO INVESTIGATE REPORTED PRESSURE ISSUE AND TESTED THE UNIT FINDING THAT PRESSURE WAS WITHIN CALIBRATION SPECIFICATION AND ALL PRESSURE LIMITS WERE WITHIN TOLERANCE. FSE FOUND NO ISSUES WITH FUNCTION OF THE INJECTOR. IF PROBLEMS PERSIST, FSE ADVISED ADDITIONAL APPLICATIONS TRAINING MAY BE NEEDED ON THIS NEWLY INSTALLED UNIT. FSE VERIFIED PROPER OPERATION ACCORDING TO OPTISTAR ELITE MR CONTRAST DELIVERY SYSTEM TEST AND INSPECTION DATA CHECKLIST 814836 AND RETURNED THE UNIT TO FULL SERVICE. A REVIEW OF GUERBET COMPLAINT TRACKING SYSTEM (CTS) SHOWED NO RELATED COMPLAINT ACTIVITY FOR THIS DEVICE. IMPACT ASSESSMENT SUMMARY. NO PATIENT HARM: (B)(4). ROOT / PROBABLE CAUSE CODE. UNKNOWN. ROOT / PROBABLE CAUSE SUMMARY. REFER TO INVESTIGATION SUMMARY. 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 REVIEW AND DURING THE MANAGEMENT REVIEW MEETINGS TO CONSIDER INPUT FOR CORRECTIVE ACTION. DISPOSITION SUMMARY. UNIT RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THIS INCIDENT WAS REPORTED BY A FACILITY IN (B)(6) ON (B)(6) 2021. THE CUSTOMER REPORTED THAT DURING A FEW CASES THEY HAVE BEEN HITTING THE PRESSURE LIMIT HARD MAKING THE SHOT LONGER, SINCE THE INJECTOR IS SLOWING DOWN THE FLOW RATE, TAKING 7 MINUTES TO COMPLETE THE INJECTION. THE REPORTER STATES THAT THE CONTRAST BEING USED, DOTAREM, LEAKED ON TABLE. THE REPORTER PROVIDED NOTES ON TWO CASES, WHERE IN THE 1ST CASE, THE PATIENT DID NOT RECEIVE TEH EXPECTED DOSE OF CONTRAST AND HAD TO DO A RESCAN. IN THE SECOND CASE, PATIENT RECIEVED ENOUGH CONTRAST TO COMPLETE THE SCAN. THE REPORTER STATES THAT THERE WAS NO INJURY TO PATIENT OR STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1533792 OPTISTAR ELITE NPS OPTISTAR ELITE NPS DXT LIEBEL-FLARSHEIM 814004 C0421D894G

    Patients

    Seq Age Sex Outcome Treatment
    1