BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MRIDIUM INFUSION PUMP

    MDR report key: 9414212 · Received December 4, 2019

    Report

    Report Number
    3005053560-2019-00005
    Event Type
    Malfunction
    Date Received
    December 4, 2019
    Date of Event
    October 10, 2019
    Report Date
    December 4, 2019
    Manufacturer
    IRADIMED CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K090087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH REPORT RECEIVED FROM FDA ON 11/04/19. REPORTER DID NOT CONTACT IRADIMED FOR THIS EVENT. THE RISK MANAGER WAS CONTACTED ON 11/04/19 FOR ADDITIONAL INFORMATION. SHE CONFIRMED NO HARM CAME TO THE PATIENT FOLLOWING THE EVENT. SHE DIRECTED ANY FURTHER QUESTIONS TO THE HOSPITAL BIOMEDICAL ENGINEERING STAFF. THE BIOMEDICAL ENGINEERING DIRECTOR HAS THE PUMP AND REPORTED THEY ATTEMPTED TO DUPLICATE THE REPORT FOLLOWING THE EVENT, BUT WERE UNABLE TO DUPLICATE THE PROBLEM. IRADIMED IS AWAITING PUMP'S EVENT LOG FROM THE HOSPITAL,AND HAS REQUESTED EXAMINATION OF THE PUMP. A FOLLOW UP REPORT WILL BE PROVIDED AFTER THE PRODUCT EXAMINATION BY IRADIMED CORPORATION.

    Description of Event or Problem · 1

    DURING THE SETUP OF MRI INFUSION OF PRECEDEX, REPORTER DESCRIBED CHANNEL B DOSE VALUE WAS SET TO 0.2 MG/KG/HR FOR A RATE OF 2.5 ML/HR. WHEN THE PUMP WAS STARTED, THE NURSE NOTED A SOUND OF RAPID INFUSION, AND A DOSE OF 50 MCG/KG/HR AT A RATE OF OVER 600 ML/HR WAS OBSERVED. THE DOCTOR CONFIRMED NO BOLUS WAS PROGRAMMED, AND STOPPED THE PUMP. APPROXIMATELY 52 MCG OF PRECEDEX HAD BEEN INFUSED IN 10 - 15 SECONDS. THE PATIENT MONITOR ALARMED FOR THE PATIENT'S SEVERE BRADYCARDIA. PATIENT WAS DISCONNECTED FROM THE PUMP, AND TREATED TO RESOLVE THE LOW HEART RATE RESULTING FROM THE INFUSION. HOSPITAL RISK MANAGER REPORTED PATIENT WAS FINE FOLLOWING THE EVENT. NO PATIENT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1208792 MRIDIUM INFUSION PUMP INFUSION PUMP FRN IRADIMED CORPORATION 3861

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention