BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MRIDIUM MRI INFUSION PUMP

    MDR report key: 2769137 · Received September 4, 2012

    Report

    Report Number
    3005053560-2012-00006
    Event Type
    Malfunction
    Date Received
    September 4, 2012
    Date of Event
    July 31, 2012
    Report Date
    September 4, 2012
    Manufacturer
    IRADIMED CORPORATION
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAD BEEN PREVIOUSLY EXAMINED BY IRADIMED CORPORATION ON (B)(4) 2012, AND FOUND TO OPERATE WITHIN SPECIFICATION. THE PUMP HAD BEEN USED BY THE HOSPITAL STAFF ON SEVERAL OCCASIONS AFTER BEING RETURNED BY IRADIMED ON (B)(4) WITHOUT ANY PROBLEMS. THIS IS A SIMILAR REPORT FROM THIS HOSPITAL WITHIN A 1 MONTH PERIOD, AND THE ANESTHESIOLOGIST IS THE SAME INDIVIDUAL WHO HAD EXPERIENCED THE INITIAL PROBLEM (SEE MEDWATCH 3005053560-2012-00004). THE INFUSION PUMP AND ADMINISTRATION SET USED DURING THIS EVENT IS AVAILABLE FOR INSPECTION AND IS BEING RETURNED BY THE HOSPITAL FOR INSPECTION WITH THE INFUSION PUMP. THESE PRODUCTS HAVE NOT YET ARRIVED AT IRADIMED CORPORATION FOR EXAMINATION. INVESTIGATION IS STILL IN PROCESS. A FOLLOW-UP REPORT WILL BE FILED WITHIN 30 DAYS OF THIS REPORT. ADDITIONAL INFO FROM THE USER FACILITY REPORT: (B)(6).

    Description of Event or Problem · 1

    DURING AN MRI INFUSION, THE ANESTHESIOLOGIST PROGRAMMED THE PUMP FOR A BOLUS DELIVERY, AND WHEN HE STARTED THE PUMP, HE NOTED THE INFUSION LINE WAS NOT DRIPPING, AS IT SHOULD WHEN THE FLUID IS FLOWING. WHEN THE PUMP WAS TURNED OFF, THE ANESTHESIOLOGIST NOTED FLUID WAS FLOWING. THE REPORTER COULD NOT INDICATE IF THE PUMP DOOR HAD BEEN OPENED OR CLOSED WHEN THE PUMP WAS TURNED OFF. THIS PROBLEM WAS DISCOVERED AS THE PT INFUSION BEGAN, AND BEFORE ANY FLUID WAS DELIVERED TO THE PT. NO PT INJURY OCCURRED. ADDITIONAL INFO FROM THE USER FACILITY REPORT: PT SCHEDULED TO HAVE MRI UNDER SEDATION. ANESTHESIOLOGIST PROGRAMMED PUMP AND CONFIRMED SETTINGS WITH RN. UPON INITIATION OF BOLUS, ANESTHESIOLOGIST NOTED PUMP WAS NOT INFUSING MEDICATION. DEVICE WAS TURNED OFF IN ORDER TO USE ANOTHER INFUSION DEVICE. AFTER THE MRIDIUM SYSTEM WAS TURNED OFF, THE MEDICATION STARTED DRIPPING IN A FREE FLOW. TUBING WAS CLAMPED BEFORE MED REACHED PT.

    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 4 YR Required Intervention