BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MRIDIUM MRI INFUSION PUMP

    MDR report key: 4577297 · Received March 2, 2015

    Report

    Report Number
    3005053560-2015-00002
    Event Type
    Malfunction
    Date Received
    March 2, 2015
    Date of Event
    January 27, 2015
    Report Date
    March 2, 2015
    Manufacturer
    IRADIMED CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K090087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFO PROVIDED INDICATES THE HOSP BELIEVES THE NURSE BROUGHT THE PT TO THE MRI NAD AFTER CONNECTING THE ALARIS SET TO THE 1058 INFUSION LINE, FLUSHED THE FLUID THROUGH THE LINE, AND AFTER ATTEMPTING TO PLACE THE 1058 LINE IN THE CHANNEL B OF THE PUMP, COULD NOT ADDRESS THE CHANNEL B ALARM, REMOVED THE SET FROM THE PUMP, AND EITHER DID NOT CLAMP OFF THE LINE, OR OPENED THE 1058 SET'S FREEFLOW PREVENTER ACCIDENTALLY DURING THE ATTEMPT TO RESOLVE THE ALARMS. THE RISK MGR ALSO INDICATED THE PUMP USED WAS DESCRIBED AS BROKEN, AND SET ASIDE FOR REPAIR, BUT WAS NOT TAGGED AS NEEDING REPAIR. BOTH CHANNELS OF THIS PUMP WERE RETURNED TO IRADIMED CORP ON 02/27/2015, AND IT WAS CONFIRMED CHANNEL B REQUIRED REPAIR.

    Description of Event or Problem · 1

    DURING THE SETUP OF AN MRI INFUSION, AN ALARIS INFUSION LINE WAS CONNECTED TO AN IRADIMED CORP 1058 EXTENSION INFUSION SET. THIS SETUP WAS BEING PREPARED FOR USE WITH CHANNEL B OF THE MRIDIUM 3860 PUMP. DURING THE PROCESS OF INSTALLING THE 1058 SET INTO THE PUMP, THE USER REPORTED CHANNEL B WAS CONSTANTLY ALARMING, AND WHEN ATTEMPTING TO RESOLVE THE ALARMS, THE MEDICATION IN THE INFUSION LINE (DOPAMINE) APPEARED TO BE FLOWING FOR A SHORT TIME DUE TO THE LINES NOT BEING CLAMPED. AT THIS TIME THE SET WAS NOT PLACED IN THE PUMP. DURING THE EVENT, THE PT WAS QUESTIONED REGARDING ANY EFFECTS OF THE DOPAMINE, AND THE PT REPORTED NO EFFECTS WERE EVIDENT. THE RISK MGR CONFIRMED NO HARM CAME TO THE PT. NO ESTIMATE OF THE AMOUNT IF DOPAMINE DELIVERED IS AVAILABLE. BOTH INFUSION SETS HAVE BEEN DISCARDED FOLLOWING THE EVENT. CHANNEL B OF THE 3860 PUMP HAD BEEN PREVIOUSLY IDENTIFIED AS REQUIRING REPAIR, BUT WAS USED FOR THIS CASE PRIOR TO ANY REPAIRS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142384 MRIDIUM MRI INFUSION PUMP INFUSION PUMP FRN IRADIMED CORPORATION 3861

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention MRIDIUM 1056 INFUSION SET,| MRIDIUM 3860 (SN (B)(4)),