BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS MEDLEY LVP BEZEL ASSEMBLY

    MDR report key: 16888493 · Received May 5, 2023

    Report

    Report Number
    MW5117364
    Event Type
    Malfunction
    Date Received
    May 5, 2023
    Date of Event
    February 17, 2023
    Report Date
    May 3, 2023
    Manufacturer
    ELITE BIOMEDICAL SOLUTIONS LLC
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN OVER INFUSION OF KETAMINE IN THE MEDICAL INTENSIVE CARE UNIT. THE INFUSION WAS BEGUN AT 0950. AT 1020, THE PUMP ALARMED FOR "AIR-IN-LINE" AND THE BAG WAS NOTED TO BE EMPTY. THE PATIENT'S VITAL SIGNS WERE STABLE AND STILL HAVING 4/4 TWITCHES ON TRAIN OF FOUR. THERE WAS PATIENT INVOLVEMENT BUT NO HARM. BD PERFORMED THE INVESTIGATION OF THE DEVICES RETURNED BY THE CUSTOMER. IT WAS FOUND THAT THE PROBABLE CAUSE OF THE COMPLAINT OF OVER INFUSION WAS BELIEVED TO BE DUE TO THE THIRD PARTY MANUFACTURED BEZEL ASSEMBLY. THE THIRD-PARTY PART WAS MANUFACTURED BY ELITE BIOMEDICAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688039 ALARIS MEDLEY LVP BEZEL ASSEMBLY PUMP, INFUSION FRN ELITE BIOMEDICAL SOLUTIONS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown