BEUDAMED
    FDA Adverse Event Death Summary report: N

    MRIDIUM INFUSION PUMP

    MDR report key: 9537155 · Received January 1, 2020

    Report

    Report Number
    3005053560-2019-00006
    Event Type
    Death
    Date Received
    January 1, 2020
    Date of Event
    December 1, 2019
    Report Date
    September 16, 2020
    Manufacturer
    IRADIMED CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K090087
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    AN ADULT MALE PATIENT WAS BEING TRANSPORTED TO THE MRI, AND WHEN THE PATIENT TRAVELED TO THE ELEVATOR, THE PATIENT CODED, POSSIBLY DUE TO AN OVER-INFUSION. THE PATIENT CODE WAS REPORTED TO HAVE OCCURRED WITHIN 2 MINUTES OF TRANSPORTING THE PATIENT. THE 100 ML FLUID CONTAINER FOR THE INFUSION WAS REPORTED TO BE EMPTY AT THIS TIME. THE INITIAL REPORTER DESCRIBED THAT THE PUMP PROVIDED AN ALARM DURING THE EVENT. PATIENT COULD NOT BE RESUSCITATED. IRADIMED HAS RECEIVED ADDITIONAL INFORMATION RELATED TO THE EVENT FROM THE HOSPITAL'S RISK MANAGER. IRADIMED HAS EVALUATED THE PUMP AND REVIEWED OF THE PUMP'S HISTORY LOG. IRADIMED HAS EXAMINED THE PUMP AND PUMP'S EVENT LOG UPON RETURN FROM THE THIRD-PARTY TEST FACILITY.

    Description of Event or Problem · 0

    CUSTOMER REPORTED A POSSIBLE OVERINFUSION. LIMITED INFORMATION HAS BEEN PROVIDED BY THE HOSPITAL. FOLLOWING SETUP OF THE PUMP, PATIENT WAS BEING TRANSFERRED TO THE MRI AND PATIENT CODED WITHIN 2 MINUTES DURING TRANSIT. PATIENT COULD NOT BE RESUSCITATED.

    Additional Manufacturer Narrative · 1

    AN ADULT MALE PATIENT WAS BEING TRANSPORTED TO THE MRI, AND WHEN THE PATIENT TRAVELED TO THE ELEVATOR, THE PATIENT CODED, POSSIBLY DUE TO AN OVER-INFUSION. THE PATIENT CODE WAS REPORTED TO HAVE OCCURRED WITHIN 2 MINUTES OF TRANSPORTING THE PATIENT. THE 100 ML FLUID CONTAINER FOR THE INFUSION WAS REPORTED TO BE EMPTY AT THIS TIME. THE INITIAL REPORTER DESCRIBED THAT THE PUMP PROVIDED AN ALARM DURING THE EVENT. PATIENT COULD NOT BE RESUSCITATED. IRADIMED HAS REQUESTED ADDITIONAL INFORMATION RELATED TO THE EVENT FROM THE HOSPITAL'S RISK MANAGER AND IS AWAITING HER RESPONSE. IRADIMED REQUESTED ACCESS TO THE PUMP FOR EXAMINATION AND REVIEW OF THE PUMP'S HISTORY LOG. THE HOSPITAL DECLINED THIS REQUEST, AND HOSPITAL'S DIRECTOR OF ENGINEERING REPORTED THEY ARE SENDING THE DEVICE TO A THIRD-PARTY TEST FACILITY FOR EXAMINATION OF THE DEVICE. IRADIMED HAS REQUESTED EXAMINATION OF THE PUMP AND PUMP'S EVENT LOG UPON RETURN FROM THE THIRD-PARTY TEST FACILITY. A FOLLOW UP REPORT WILL BE PROVIDED AFTER THE PRODUCT EXAMINATION BY IRADIMED CORPORATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A POSSIBLE OVER INFUSION. LIMITED INFORMATION HAS BEEN PROVIDED BY THE HOSPITAL. FOLLOWING SETUP OF THE PUMP, PATIENT WAS BEING TRANSFERRED TO THE MRI AND PATIENT CODED WITHIN 2 MINUTES DURING TRANSIT. PATIENT COULD NOT BE RESUSCITATED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Death MRIDIUM 3860 INFUSION PUMP, SN (B)(6)| MRIDIUM 3860 INFUSION PUMP, SN (B)(6)