BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LVP BEZEL ASSY NOEM

    MDR report key: 18846244 · Received March 5, 2024

    Report

    Report Number
    MW5152340
    Event Type
    Malfunction
    Date Received
    March 5, 2024
    Date of Event
    December 26, 2023
    Report Date
    March 1, 2024
    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 AN UNSPECIFIED FLUID WAS PROGRAMMED TO INFUSE FOR SEVEN (7) HOURS. HOWEVER, IT WAS COMPLETED IN 40 MINUTES. THERE WAS PATIENT INVOLVEMENT BUT NO HARM. THE MEDICATION INVOLVED WAS PROPOFOL, ORDERED TO INFUSE AT 14.1ML/HR. (30MCG/KG/HR.). PER BD ALARIS MANUFACTURER'S INVESTIGATION: THE ROOT CAUSE OF THE REPORT THAT THE USER PROGRAMMED A SEVEN HOUR INFUSION BUT COMPETED IN FORTY MINUTES WAS DETERMINED TO BE DUE TO USE OF A THIRD-PARTY BEZEL (BEZEL MANUFACTURED BY ELITE BIOMEDICAL SOLUTIONS). THE THIRD-PARTY BEZEL ASSEMBLY INSTALLED WAS A CONTRIBUTING FACTOR TO THE REPORTED OVER INFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144497 LVP BEZEL ASSY NOEM ACCESSORIES, PUMP, INFUSION MRZ ELITE BIOMEDICAL SOLUTIONS, LLC. 49000270 49000270

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown PROPOFOL