BEUDAMED
    FDA Adverse Event Death Summary report: N

    MRIDIUM

    MDR report key: 22031137 · Received May 15, 2025

    Report

    Report Number
    3005053560-2025-00003
    Event Type
    Death
    Date Received
    May 15, 2025
    Date of Event
    April 3, 2025
    Report Date
    May 15, 2025
    Manufacturer
    IRADIMED CORPORATION
    Product Code
    FRN
    UDI-DI
    00856038001089
    PMA / PMN Number
    K143369
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY LOG SUGGESTED THAT THE USER LIKELY HAD ISSUES PRIMING THE IV SET LINE. A "BUBBLE DETECTOR ACTIVITY" WAS LOGGED, INDICATING THAT THE BUBBLE DETECTOR WAS ACTIVE AND DETECTED A BUBBLE BELOW THE ALARM THRESHOLD IMMEDIATELY AFTER THE INFUSION STARTED. SUBSEQUENTLY, A "BUBBLE DETECTED" ALARM OCCURRED SHORTLY AFTER THE INFUSION BEGAN. THIS WAS CONSISTENT WITH THE EVENT DESCRIPTION PROVIDED BY THE BIOMED, WHERE THE USER OBSERVED AIR IN THE IV SET WHEN THE "BUBBLE DETECTED" ALARM WAS TRIGGERED. THE PRESENCE OF THE "BUBBLE DETECTED" ALARM, OCCURRING AFTER THE INFUSION PARAMETERS WERE SET AND IMMEDIATELY AFTER THE INFUSION BEGAN, STRONGLY INDICATED THAT AIR WAS PRESENT IN THE IV LINE AT THE START OF THE INFUSION. PROPER PRIMING OF THE IV SET IS CRUCIAL TO REMOVE ALL AIR FROM THE TUBING BEFORE CONNECTING IT TO THE PATIENT AND INITIATING THE INFUSION. THE OPERATOR'S MANUAL AND THE IV SET POUCH LABEL CONTAINED INSTRUCTIONS ON HOW TO PROPERLY PRIME THE IV SET. THE DEVICE HISTORY LOG SHOWED THAT THE USER OPENED THE DOOR AFTER THE BUBBLE ALARM, POTENTIALLY ATTEMPTING TO TROUBLESHOOT THE ISSUE. ALL ALARMS WERE SILENCED BY THE USER BEFORE THE INFUSION WAS CANCELED. A BUBBLE ALARM IN THIS CONTEXT IS A COMMON SIGN THAT THE PRIMING STEP MAY HAVE BEEN INSUFFICIENT, MISSED, OR THAT THE USER EXPERIENCED DIFFICULTY PRIMING AND SETTING UP THE LINE. THIS COULD HAVE LED TO AIR BEING DETECTED BY THE PUMP AND MAY HAVE RESULTED IN A DELAY OF THERAPY. THE CUSTOMER CONFIRMED THAT THE PATIENT CODED DURING THE EVENT AND THAT MEDICAL INTERVENTION WAS REQUIRED. THEREFORE, IRADIMED IS REPORTING THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A POTENTIAL UNDER-INFUSION EVENT. ACCORDING TO BIOMED, THE MRI TECHNICIAN OBSERVED A BUBBLE OF AIR IN THE IV LINE. HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING WHETHER ANY ALARMS OCCURRED DURING THE EVENT. PER BIOMED THE PATIENT CODED DURING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73407 MRIDIUM INFUSION PUMP FRN IRADIMED CORPORATION 00856038001089

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death