BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MRIDIUM 3860+ INFUSION PUMP

    MDR report key: 6295022 · Received February 1, 2017

    Report

    Report Number
    3005053560-2016-00002
    Event Type
    Malfunction
    Date Received
    February 1, 2017
    Date of Event
    February 11, 2016
    Report Date
    April 18, 2016
    Manufacturer
    IRADIMED CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K090087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MRIDIUM PUMP WAS RETURNED TO THE IRADIMED FOR EVALUATION ON APRIL 11, 2016. THE INFUSION SET USED DURING THE EVENT IS NOT AVAILABLE FOR EXAMINATION. THE INITIAL REPORTER (NON-HOSPITAL) REPORTED TO IRADIMED CORPORATION THAT THE PUMP WAS DAMAGED IN TRANSIT TO THEIR FACILITY. THE PUMP WAS FUNCTIONAL, BUT THE EFFECT OF THIS DAMAGE TO THE PUMP IS BEING EVALUATED. THE INITIAL REPORTER (NON-HOSPITAL) REPORTED THAT THE PUMP'S FLOW RATE WAS TESTED AND MET THE PRODUCT SPECIFICATION. A FOLLOW-UP REPORT WILL BE PROVIDED WITHIN 45 DAYS ONCE THE PRODUCT EVALUATION HAS BEEN COMPLETED AT IRADIMED CORPORATION. MEDWATCH REPORT # MW5060594 WAS RECEIVED FROM FDA FOR THIS EVENT.

    Description of Event or Problem · 1

    INITIAL REPORTER (NON-HOSPITAL) CONTACTED IRADIMED CORPORATION FOR INFORMATION REGARDING SERVICE AND TESTING INFORMATION. UPON FOLLOW UP, HOSPITAL WAS ASKED TO PROVIDE EVENT DETAILS TO IRADIMED, WHICH OCCURRED ON (B)(6) 2016. HOSPITAL REPORTED DELIVERED EXCESS BOLUS OF PROPOFOL DURING AN INFUSION. IT IS BELIEVED AS MUCH AS 60 ML EXCESS FLUID WAS DELIVERED. WHEN PATIENT BECAME HYPOTONIC, STAFF RESPONDED AND DISCONTINUED THE INFUSION. PATIENT RECOVERED WITHOUT INCIDENT. NO INJURY RESULTED FROM THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75329 MRIDIUM 3860+ INFUSION PUMP INFUSION PUMP FRN IRADIMED CORPORATION 3860

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention MRIDIUM 3861 CHANNEL B PUMP, SN (B)(4)