BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS MEDLEY LVP BEZEL ASSEMBLY

    MDR report key: 16753678 · Received April 14, 2023

    Report

    Report Number
    MW5116715
    Event Type
    Malfunction
    Date Received
    April 14, 2023
    Date of Event
    December 22, 2022
    Report Date
    April 12, 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 THE ON (B)(6) 2022, THE PUMP MODULE WAS PROGRAMMED AT 1746 TO INFUSE PRECEDEX AT 11.6ML/HR. THERE WAS ALLEGEDLY A FREE FLOW EVENT. THERE WAS PATIENT INVOLVEMENT BUT NO HARM. BD PERFORMED THE INVESTIGATION OF THE DEVICE RETURNED BY THE CUSTOMER. IT WAS FOUND THAT THE ROOT CAUSE OF THE COMPLAINT OF OVER INFUSION IS BEING ATTRIBUTED TO A DAMAGED THIRD-PARTY BEZEL ASSEMBLY. THE THIRD-PARTY PART WAS MANUFACTURED BY ELITE BIOMEDICAL. .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1373269 ALARIS MEDLEY LVP BEZEL ASSEMBLY PUMP, INFUSION FRN ELITE BIOMEDICAL SOLUTIONS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown