BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MRIDIUM MRI INFUSION PUMP

    MDR report key: 2900229 · Received October 12, 2012

    Report

    Report Number
    3005053560-2012-00014
    Event Type
    Malfunction
    Date Received
    October 12, 2012
    Date of Event
    September 18, 2012
    Report Date
    October 19, 2012
    Manufacturer
    IRADIMED CORPORATION
    Product Code
    FRN
    Removal / Correction Number
    3005053560-09/17/12/002-
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE THIRD SIMILAR REPORT FROM THIS HOSPITAL WITHIN A TWO MONTH PERIOD, (SEE MEDWATCH REPORTS (B)(4)). THE ANESTHESIOLOGIST INVOLVED WITH THIS THIRD EVENT WAS NOT THE SAME INDIVIDUAL AS IN THE PRIOR TWO EVENTS. THE PUMP WAS RETURNED TO IRADIMED CORPORATION ON (B)(4) 2012 AND FOUND TO OPERATE WITHIN SPECIFICATION. THE PUMP'S HISTORY EVENT LOG WAS REVIEWED AND THE PUMP WAS USED THREE TIMES PRIOR TO THE EVENT ON (B)(4) 2012 WITHOUT ANY PROBLEMS. THE EXAMINATION OF THE PUMP'S HISTORY/EVENT LOG DID NOT IDENTIFY ANY ACTION THAT CAN ACCOUNT FOR THE EVENT. THE INFUSION ADMINISTRATION SET USED DURING THIS EVENT IS NOT AVAILABLE FOR INSPECTION, AS IT WAS DISCARDED FOLLOWING THE EVENT BY THE HOSPITAL. FROM THE INVESTIGATION AVAILABLE, THE LIKELY CAUSE OF THIS REPORT WAS THE INCORRECT POSITIONING OF THE INFUSION SET IN THE PUMP BY THE USER. THE PROPER METHOD OF INSTALLATION IS DESCRIBED IN THE OPERATOR'S MANUAL. THE INSTRUCTIONS WARN THAT STRETCHING THE TUBING, OR MALPOSITIONING THE TUBING, CAN RESULT IN FREE-FLOW CONDITIONS. IN RESPONSE TO THIS AND OTHER SIMILAR REPORTS, IRADIMED CORPORATION INITIATED CORRECTION NUMBER (B)(4) ON (B)(4) 2012 TO NOTIFY USERS OF THE POSSIBILITY OF THIS RISK. THESE SAME INSTRUCTIONS ARE PROVIDED IN THE OPERATOR'S MANUAL, BUT AN ADDITIONAL INSTRUCTION CARD WAS PROVIDED TO USERS TO EMPHASIZE THESE IMPORTANT INSTRUCTIONS AND PRECAUTIONS. THIS CUSTOMER RECEIVED THE CORRECTION NOTICE ON (B)(4) 2012, BUT RECOMMENDATIONS HAD NOT BEEN IMPLEMENTED BY (B)(4) 2012. A SECOND COPY OF THE NOTICE WAS PROVIDED BY E-MAIL ON (B)(4) 2012. FOLLOWING THIS EVENT, AN IRADIMED CORPORATION REPRESENTATIVE VISITED THIS FACILITY TO PERFORM ADDITIONAL IN-SERVICE TRAINING FOR THEIR STAFF.

    Description of Event or Problem · 1

    A (B)(6) MALE WITH DEVELOPMENTAL DELAY AND HYDRONEPHROSIS WAS SCHEDULED FOR MRI OF THE BRAIN C, T, L SPINE, ABDOMEN, AND PELVIS. HALFWAY THROUGH THE MRI, THE ANESTHESIOLOGIST NOTED THE PT WAS DESATURATING. UPON ASSESSMENT OF THE PT, THE DR NOTED THE PROPOFOL VIAL WAS EMPTY (50 MG/ 50 CC). THE MRIDIUM INFUSION DEVICE WAS SET TO AN INITIAL VOLUME OF 25 CC AND THE VTBI DISPLAY READ 12 CC ALTHOUGH THE PROPOFOL VIAL WAS EMPTY. THE PT REQUIRED LIGHT AIRWAY MEASURES, AS WELL AS A SMALL AMOUNT OF EPHEDRINE FOR A DECREASE IN BLOOD PRESSURE. THERE WAS NO HARM TO THE PT AND THE MRI WAS COMPLETED USING A DIFFERENT INFUSION DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MRIDIUM MRI INFUSION PUMP INFUSION PUMP FRN IRADIMED CORPORATION 3860

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Required Intervention