BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELITE BIOMEDICAL BEZEL ASSEMBLY PUMP

    MDR report key: 16436598 · Received February 23, 2023

    Report

    Report Number
    MW5115145
    Event Type
    Malfunction
    Date Received
    February 23, 2023
    Report Date
    February 17, 2023
    Manufacturer
    ELITE BIOMEDICAL SOLUTIONS LLC.
    Product Code
    MRZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT MORPHINE INFUSED OVER FIVE (5) HOURS, HOWEVER WAS ORDERED TO INFUSE OVER TWENTY-FOUR (24) HOURS. THERE WAS NO PATIENT HARM. BD PERFORMED INVESTIGATION, IT WAS FOUND THE ROOT CAUSE OF THE REPORTED OVER INFUSION WAS DETERMINED TO BE DUE TO A THIRD-PARTY BEZEL ASSEMBLY. THE THIRD PART WAS MANUFACTURED BY ELITE BIOMEDICAL. THIRD PARTY PARTS HAVE NOT BEEN VALIDATED BY BD FOR SAFETY AND EFFICACY WITH ALARIS SYSTEM PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752641 ELITE BIOMEDICAL BEZEL ASSEMBLY PUMP ACCESSORIES, PUMP, INFUSION MRZ ELITE BIOMEDICAL SOLUTIONS LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown