BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MRIDIUM MRI INFUSION PUMP

    MDR report key: 4181112 · Received August 4, 2014

    Report

    Report Number
    3005053560-2014-00007
    Event Type
    Malfunction
    Date Received
    August 4, 2014
    Date of Event
    June 25, 2014
    Report Date
    July 31, 2014
    Manufacturer
    IRADIMED CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K090087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSIONS: IRADIMED CORP'S EXAMINATION OF THE PUMP'S HISTORY/EVENT LOG IDENTIFIED A USER ENTRY THAT COULD HAVE BEEN THE RESULT FROM PUMP MIS-PROGRAMMING FROM ANOTHER NEARBY 3865 REMOTE DISPLAY SET ON THE SAME RADIO-LINKED CHANNEL. FROM THE INFO AVAILABLE, THE POSSIBLE CAUSES(S) OF THIS REPORT INCLUDE: THE USER'S FAILURE TO OPERATE MULTIPLE INFUSION PUMPS ON THE SAME RADIO-LINK CHANNEL, WHICH IS CONTRAINDICATED IN THE PRODUCT'S INSTRUCTIONS. THE USER'S FAILURE TO PROPERLY VERIFY THE COMMUNICATION BETWEEN THE PUMP AND REMOTE DISPLAY AFTER ASSOCIATION BETWEEN THE PUMP AND REMOTE DISPLAY.

    Description of Event or Problem · 1

    DURING AN MRI SCAN A MRIDIUM 3860 WAS BEING USED TO PROVIDE AN INFUSION TO A PATIENT, AND THE 3860 PUMP WAS ASSOCIATED THROUGH ITS WIRELESS 2.4 GHZ RADIO-LINK A 3865 REMOTE DISPLAY REMOTE DISPLAY IN THE MRI CONTROL ROOM. DURING THE CASE THE PUMP LOST ITS RADIO LINK WITH THE REMOTE DISPLAY, AND THERE WAS NO LINK FOR MORE THAN 25 MINUTES. WHEN THE PUMP RESUMED THE RADIO-LINK, THE PUMP'S RATE WAS CHANGED BY A USER FROM 44 ML/HR TO 150 ML/HR. THIS INFUSION CONTINUED FOR APPROX 15 MINUTES WHEN THE INFUSION WAS STOPPED THEN REPROGRAMMED TO CONTINUE AT 44 ML/HR UNTIL THE END OF THE CASE. AN INQUIRY FROM THE HOSPITAL REQUESTED ASSISTANCE IN REVIEWING THE PUMP'S HISTORY EVENT LOG TO DETERMINE IF IT WAS POSSIBLE IF ANOTHER NEARBY 3865 REMOTE DISPLAY COULD HAVE BEEN ASSOCIATED WITH THIS PUMP. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EFFECTS OR INJURY RESULTING FROM THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453467 MRIDIUM MRI INFUSION PUMP INFUSION PUMP FRN IRADIMED CORPORATION 3860

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention MRIDIUM 3865, SN#: UNK