BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INJECTOR OPVSU SI NPS

    MDR report key: 15370428 · Received September 7, 2022

    Report

    Report Number
    1518293-2022-00009
    Event Type
    Injury
    Date Received
    September 7, 2022
    Date of Event
    August 1, 2022
    Report Date
    August 10, 2022
    Manufacturer
    LIEBEL-FLARSHEIM
    Product Code
    IZQ
    PMA / PMN Number
    K063503
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OVERALL INVESTIGATION SUMMARY- A COMPLAINT WAS RECEIVED FROM A GUERBET APPLICATIONS SPECIALIST ON OPTIVANTAGE INJECTOR 849001 SERIAL NUMBER (B)(4) WHERE THE CUSTOMER REPORTED AN AIR INJECTION OF APPROXIMATELY 100ML ON A PATIENT UNDERGOING A CTA CORONARY PROCEDURE. THE TECHNICIAN REPORTED THAT THE OPTIVANTAGE SYRINGES WERE LOADED WITH 100ML OF OMNIPAQUE 350 AND 50ML OF SALINE, THEN AUTO PURGED THE TUBING FOLLOWED BY THE MANUAL TWIST OF THE SALINE KNOB. THE TUBING WAS THEN HOOKED UP TO THE PATIENTS IV AND THE EXAMS BEGUN. DURING THE SCAN, AIR WAS NOTED IN THE TEST INJECTION AND THE INJECTION WAS STOPPED. CUSTOMER REPORTED THAT THE AMOUNT OF AIR INJECTED WAS APPROX. 100 ML. THE PATIENT, COMPLAINING OF CHEST PAINS, WAS TRANSPORTED TO ER FOR OBSERVATION AND THEN DISCHARGED THE FOLLOWING DAY WITH NO ADVERSE EFFECTS. CUSTOMER DID NOT ASK GUERBET SERVICE TO EVALUATE THE INJECTOR BUT DID ASK GUERBET APPLICATIONS SPECIALIST TO COME BACK ON SITE TO DO SOME RETRAINING AS THE CUSTOMER BELIEVES THE INCIDENT COULD BE RELATED TO USER ERROR. A REVIEW OF GUERBET COMPLAINT TRACKING SYSTEM (CTS) SHOWED NO RELATED COMPLAINT ACTIVITY FOR THIS DEVICE. IMPACT ASSESSMENT SUMMARY- AIR INJECTED INTO PATIENT, NO ADVERSE EFFECTS REPORTED AFTER DISCHARGE OF PATIENT. ROOT / PROBABLE CAUSE CODE- PERSONNEL - TRAINING - INADEQUATE. ROOT / PROBABLE CAUSE SUMMARY- REFER TO INVESTIGATION SUMMARY. AS SERVICE WAS NOT ASKED TO EVALUATE CUSTOMERS EQUIPMENT AND NOTHING WAS REPORTED WRONG WITH THE DEVICE, NO CORRECTIVE ACTION WAS POSSIBLE. ALTHOUGH NO ADDITIONAL CAPA IS 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 REVIEW MEETINGS TO CONSIDER INPUT FOR ADDITIONAL CORRECTIVE ACTION. DISPOSITION SUMMARY: UNIT REMAINED IN SERVICE.

    Description of Event or Problem · 0

    THIS INCIDENT WAS REPORTED BY A FACILITY IN (B)(6) ON (B)(6) 2022. THE REPORTER STATES THAT PATIENT WAS SCHEDULED FOR A CTA CORONARY. PATIENT WAS HOOKED UP TO THE MONITOR AND CONTRAST INJECTOR. DURING THE SCAN AIR WAS NOTED IN THE TEST INJECTION. THE INJECTION WAS STOPPED. THE TOTAL AMOUNT OF AIR INJECTED WAS APPROX 100 ML. THE TECH IS SURE SHE LOADED THE OPTIVANTAGE SYRINGE WITH 100ML'S OF OMNIPAQUE 350 AND 50ML'S OF SALINE. TECH AUTO PURGED THE TUBING FOLLOWED BY THE MANUAL TWIST OF THE SALINE KNOB. THE TUBING WAS THEN HOOKED UP TO THE PATIENTS IV AND THE EXAMS BEGUN. DR. (B)(6) WAS NOTIFIED TO ASSESS THE PATIENT. BP WAS 90/90 AND PATIENT WAS COMPLAINING OF CHEST PAIN. TRY AC IV WAS NOT WORKING. RESTARTED IV IN THE LEFT A AND PATIENT GIVEN 500ML OF .09 SALINE. AMBU BAG WAS USED TO PROVIDE OXYGEN. 911 WAS CALLED TO TRANSPORT TO ER FOR OBSERVATION. PATIENT DISCHARGED FROM HOSPITAL ON (B)(6) 2022. SITE FOLLOWED UP WITH PATIENT AND HE HAD NO COMPLAINTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1737869 INJECTOR OPVSU SI NPS INJECTOR OPVSU SI NPS IZQ LIEBEL-FLARSHEIM 849001 C0821B541G

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other