BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MRIDIUM MRI INFUSION PUMP

    MDR report key: 3099432 · Received April 23, 2013

    Report

    Report Number
    3005053560-2013-00004
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    March 18, 2013
    Report Date
    April 19, 2013
    Manufacturer
    IRADIMED CORPORATION
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORT WAS RECEIVED FROM THE HEALTH CARE PROFESSIONAL INDICATED THAT THE DEVICE (INFUSION PUMP) WAS EXAMINED BY THE HOSPITAL STAFF. INFORMATION WAS OBTAINED FROM THE CUSTOMER INTERVIEWS, AND THE INSPECTION OF THE EQUIPMENT AT IRADIMED CORPORATION. THE MRI MANAGER, BIOMEDICAL ENGINEERING, AND MRI NURSE COORDINATOR WERE INTERVIEWED REGARDING THE EVENT, THE USE OF THE DEVICE, AND THE PUMP'S HISTORY EVENT LOG INFORMATION WAS OBTAINED FOR THE TIME OF THE EVENT. INFORMATION GATHERED DURING THIS PERIOD WAS USED TO ATTEMPT TO RECONSTRUCT THE EVENT TO ESTABLISH THE POSSIBLE CAUSE(S) OF THE EVENT. ON (B)(6) 2013, DURING AN MRI SCAN, THE HOSPITAL HAD REPORTED THAT THE 3860 PUMP WAS PROGRAMMED TO DELIVER PROPOFOL AT A FLOW RATE OF 25 ML/HR FOR A VOLUME OF 100 ML. A SHORT TIME AFTER THIS THE ANESTHESIOLOGIST NOTED THE 50 ML FLUID CONTAINER WAS EMPTY, AND THE ANESTHESIOLOGIST TOOK STEPS TO MANAGE THE PATIENT, AND THE MR PROCEDURE CONTINUED WITHOUT FURTHER INCIDENT. THE PATIENT WAS A (B)(6) YEAR OLD CHILD. THE PATIENT RECOVERED WITHOUT INCIDENT, AND NO INJURY RESULTED FROM THIS EVENT. AT THE TIME OF THE EVENT, A STANDARD INFUSION SET (IRADIMED CORPORATION TYPE 1056 SET) WAS IN USE WITH THE PUMP, WHICH WAS NOT PROVIDED TO IRADIMED CORPORATION FOR EXAMINATION. THE HOSPITAL DISCARDED THE INFUSION SET FOLLOWING THE EVENT. ON MARCH 26, 2013 IRADIMED CORPORATION HAD A REPRESENTATIVE VISIT THE FACILITY TO REVIEW THE OPERATION OF THE PRODUCT, AND PROVIDE ADDITIONAL TRAINING TO THE HOSPITAL STAFF AT THE REQUEST OF THE HOSPITAL' S NURSING COORDINATOR. PRODUCT EXAMINATION: ON MARCH 27, 2013, THE PUMP USED DURING THE EVENT WAS EXAMINED BY IRADIMED CORPORATION. DURING THIS EXAMINATION IT WAS NOTED THE PUMP'S DOOR SPRING LATCH WAS DAMAGED, AND THIS COULD HAVE MADE THE PUMP' S DOOR DIFFICULT TO CLOSE. THIS CONDITION SHOULD HAVE BEEN RECOGNIZED BY THE USER, AND THIS PROBABLY DID CONTRIBUTE TO THE EVENT. INVESTIGATION CONCLUSIONS: FROM THE INFORMATION AVAILABLE, NO FIRM CONCLUSIONS CAN BE MADE AS TO WHAT CAUSED THIS EVENT. THE PROBABLE CAUSE OF THE MISSING INFUSION FLUID MAY HAVE BEEN FAILURE TO RESPOND TO THE "CHECK DOOR" ALARM THAT WOULD INDICATE A FREE-FLOW CONDITION WAS OCCURRING. THE FREQUENT "CHECK DOOR" ALARMS WERE NOT ADDRESSED BY A SERVICE REPRESENTATIVE, AS IDENTIFIED IN THE OPERATOR'S MANUAL. WHEN THIS MESSAGE OCCURS, THE USER IS INSTRUCTED TO RESPOND TO THE ALARM IMMEDIATELY TO PREVENT A POSSIBLE FREE-FLOW CONDITION. ADDITIONALLY, FOLLOW-UP IN-SERVICE TRAINING WAS PROVIDED ON MARCH 26, 2013 BY IRADIMED CORPORATION TO THE FACILITY'S STAFF. THE PUMP WAS REPAIRED AND RETURNED TO THE CUSTOMER ON MARCH 27, AND INFORMATION REGARDING THE PROBABLE CAUSE OF THE EVENT WAS PROVIDED TO THE CUSTOMER ON APRIL 18, 2013. NO OTHER ACTION IS CONSIDERED NECESSARY AT THIS TIME.

    Description of Event or Problem · 1

    DURING AN MRI SCAN, THE HOSPITAL HAD REPORTED THAT THE INFUSION PUMP WAS PROGRAMMED TO DELIVER PROPOFOL. AT SOME POINT AFTER THE INFUSION WAS STARTED, THE ANESTHESIOLOGIST NOTED THE 50 ML FLUID CONTAINER WAS EMPTY, AND THE ANESTHESIOLOGIST TOOK STEPS TO MANAGE THE PATIENT. THE MRI PROCEDURE CONTINUED WITHOUT FURTHER INCIDENT. NO PATIENT INJURY RESULTED FROM THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175756 MRIDIUM MRI INFUSION PUMP INFUSION PUMP FRN IRADIMED CORPORATION 3860

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention