BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MRIDIUM MRI INFUSION PUMP

    MDR report key: 2764466 · Received September 25, 2012

    Report

    Report Number
    3005053560-2012-00008
    Event Type
    Malfunction
    Date Received
    September 25, 2012
    Date of Event
    August 9, 2012
    Report Date
    September 22, 2012
    Manufacturer
    IRADIMED CORPORATION
    Product Code
    FRN
    Removal / Correction Number
    3005053560-09/17/12-002-
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN EXAMINED BY IRADIMED CORPORATION. EXAMINATION OF THE 3861 DETERMINED NO MALFUNCTION OF THE PUMP COULD EXPLAIN THE REPORTED EVENT. THE INFUSION SET USED AT THE TIME OF THE EVENT WAS DISCARDED BY THE HOSPITAL, BUT THE HOSPITAL BELIEVED IT WAS A 1056 STANDARD INFUSION SET. THE EXAMINATION OF THE PUMP'S HISTORY/EVENT LOG DID NOT IDENTIFY ANY ACTION THAT CAN ACCOUNT FOR THE EVENT. FROM THE INFO AVAILABLE, THE LIKELY CAUSE OF THIS REPORT WAS THE INCORRECT POSITIONING OF THE INFUSION SET IN THE PUMP BY THE USER. THE PROPER METHOD OF INSTALLATION IS DESCRIBED IN THE OPERATOR'S MANUAL (SEE ATTACHED SECTION). THE INSTRUCTIONS WARN THAT STRETCHING THE TUBING, OR MISPOSITIONING THE TUBING CAN RESULT IN FREE-FLOW CONDITIONS. IN RESPONSE TO THIS AND OTHER SIMILAR REPORTS, IRADIMED CORPORATION INITIATED CORRECTION NO. 3005053560-09/17/12-002-C ON 8/31/2012 TO NOTIFY USERS OF THE POSSIBILITY OF THIS RISK. THESE SAME INSTRUCTIONS ARE PROVIDED IN THE OPERATOR'S MANUAL, BUT AN ADD'L INSTRUCTION CARE WAS PROVIDED TO USERS TO EMPHASIZE THESE IMPORTANT INSTRUCTIONS AND PRECAUTIONS. COPIES OF THE CORRECTION AND INSTRUCTION CARD TEXT PROVIDED WITH THIS REPORT.

    Description of Event or Problem · 1

    DURING AN MRI INFUSION, THE HOSPITAL REPORTED AN EXCESS AMOUNT OF FLUID FLOWED TO THE PT. THE FLUID BEING INFUSION WAS SALINE, AND NO HARM CAME TO THE PT. NO PT INJURY OCCURRED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention MRIDIUM PUMP 3860 (SN(B)(4)) WAS ATTACHED| TO THE 3861 DURING THE EVENT.