BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MRIDIUM MRI INFUSION PUMP

    MDR report key: 4178333 · Received September 15, 2014

    Report

    Report Number
    3005053560-2014-00008
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    July 31, 2014
    Report Date
    September 12, 2014
    Manufacturer
    IRADIMED CORPORATION
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    HOSPITAL BIOMEDICAL ENGINEER PERFORMED EXAMINATION OF THE INFUSION PUMP AND CONFIRMED THE PUMP OPERATED NORMALLY, AND COULD NOT FIND A MALFUNCTION AS CAUSE OF THE REPORT. THE PUMP WAS RETURNED TO IRADIMED CORPORATION FOR EVALUATION, AND NO PROBLEM WAS FOUND THAT COULD RESULT IN THIS EVENT. THE REPORTER INDICATED THAT THE INFUSION SET WAS RETAINED AND IT HAS BEEN REQUESTED THAT THE INFUSION SET BE RETURNED FOR EVALUATION WITH THE CUSTOMER'S, PUMP. IRADIMED CORPORATION IS AWAITING THE RECEIPT OF THIS INFUSION SET. ONCE THIS INFUSION SET HAS BEEN RECEIVED AND EVALUATED, A F/U REPORT WILL BE PROVIDED. THIS REPORT SHOULD BE PROVIDED WITHIN 30 DAYS OF THIS REPORT.

    Description of Event or Problem · 1

    DURING AN MRI INFUSION, THE NURSE WAS SETTING UP THE PUMP, AND THE PUMP INDICATED TO LOAD THE INFUSION SET. THE NURSE REPORTED SHE REMOVED THE SET AT LEAST THREE TIMES TO CLEAR THE LOAD SET MESSAGE, AND SUBSEQUENTLY FOUND THE 50 ML MEDICATION CONTAINER WAS EMPTY. THE REPORTER INDICATED THEY BELIEVED THE PT RECEIVED "34 MG" OF TPA-ACTIVASE IN APPROXIMATELY 5 MINS. THE PT WAS TAKEN TO THE ICU AFTERWARD FOR MONITORING AND TREATMENT. THERE WAS NO REPORT OF ANY PT UNTOWARD ADVERSE EFFECTS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568128 MRIDIUM MRI INFUSION PUMP INFUSION PUMP FRN IRADIMED CORPORATION 3860

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention