BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTISTAT INJECTOR

    MDR report key: 14547785 · Received May 31, 2022

    Report

    Report Number
    1518293-2022-00004
    Event Type
    Malfunction
    Date Received
    May 31, 2022
    Date of Event
    May 3, 2022
    Report Date
    May 3, 2022
    Manufacturer
    LIEBEL-FLARSHEIM
    Product Code
    DXT
    PMA / PMN Number
    K022116
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OVERALL INVESTIGATION SUMMARY: A COMPLAINT WAS RECEIVED ON OPTISTAT INJECTOR 810150 SN (B)(4) ALLEGING THE FOLLOWING ERRORS: ERROR U001 - USER ATTEMPTED TO START AN INJECTION FROM THE POWERHEAD WHEN THE INJECTION IS NOT ENABLED AND ERROR U003 - RAM NOT AT HOME POSITION AFTER POWER-UP. IT WAS ALSO REPORTED THAT AN EXTRAVASATION OF CONTRAST OCCURRED WITH THE PATIENT, ALLEGEDLY AS A RESULT OF THE INJECTOR BEGINNING TO INCREASE THE INJECTION FLOW RAPIDLY FROM 2.1ML/SEC TO 2.4ML/SEC. BASED ON A CONVERSATION THE CUSTOMER HAD WITH THE PATIENT AFTER THE PROCEDURE, THE PATIENT REPORTED NO DISCOMFORT AND ALL OF THE SWELLING HAD DISAPPEARED. SERVICE ENGINEER INVESTIGATED THE INJECTOR AND DETERMINED THAT THE INJECTOR WAS NOT BEING USED CORRECTLY BY THE END USER, WHICH CAUSED THE USER ERRORS. WHEN TESTED BY THE SERVICE ENGINEER, THE INJECTOR FUNCTIONED NORMALLY WITH THE CORRECT PROGRAMMING. SERVICE ENGINEER COMPLETED PERFORMANCE TESTS ACCORDING TO SERVICE MANUAL 810807-B AND THE EQUIPMENT WAS OPERATING PROPERLY. THE INJECTOR WAS RETURNED TO SERVICE. IT IS NOT THOUGHT THAT THE REPORTED EXTRAVASATION EVENT HAD ANYTHING TO DO WITH THE USER ERRORS U001 AND U003, OR THE INJECTOR. AS DOCUMENTED BY THE AMERICAN COLLEGE OF RADIOLOGY (ACR), AN INJECTOR CANNOT CAUSE PRESSURE BUILD UP IN THE PATIENT'S VEIN. PER VERSION 8 OF THE ACR MANUAL ON CONTRAST MEDIA: "THE REPORTED INCIDENCE OF INTRAVENOUS (IV) CONTRAST MEDIA EXTRAVASATION RELATED TO POWER INJECTION FOR CT HAS RANGED FROM 0.1% TO 0.9% (1/1,000 PATIENTS TO 1/106 PATIENTS). EXTRAVASATION CAN OCCUR DURING HAND OR POWER INJECTION. THE FREQUENCY OF EXTRAVASATION IS NOT RELATED TO THE INJECTION FLOW RATE. EXTRAVASATION OCCURRING WITH DYNAMIC BOLUS CT MAY INVOLVE LARGE VOLUMES OF CONTRAST MEDIA". A REVIEW OF GUERBET COMPLAINT TRACKING SYSTEM (CTS) SHOWED NO RELATED COMPLAINT ACTIVITY FOR THIS DEVICE. IMPACT ASSESSMENT SUMMARY: (B)(4). REFER TO INVESTIGATION SUMMARY. 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 · 0

    THIS INCIDENT WAS REPORTED BY A FACILITY IN QUILLOTA, CHILE ON (B)(6) 2022. THE REPORTER STATES THERE WAS AN INJURY TO A PATIENT AS A RESULT OF THE INJECTOR BEGINNING TO INCREASE THE INJECTION FLOW RAPIDLY FROM 2.1ML/SEC TO 2.4ML/SEC, CAUSING THE PATIENT'S VEIN TO COLLAPSE AND GENERATING AN EXTRAVASATION OF THE CONTRAST MEDIUM. THE CONTRAST MEDIUM USED WAS OPTIRAY 320 100 ML, LOT: P3018 AND THAT THE INJECTOR RECENTLY PRESENTED A NEW PROBLEM, TURNING OFF PRIOR TO THE INJECTION OF THE CONTRAST MEDIUM WHEN CONNECTED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1186162 OPTISTAT INJECTOR OPTISTAT INJECTOR DXT LIEBEL-FLARSHEIM 810150 C0120G059X

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown