BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELITE BIOMEDICAL SOLUTIONS THIRD PARTY PARTS FOR PUMP

    MDR report key: 15799148 · Received November 14, 2022

    Report

    Report Number
    MW5113239
    Event Type
    Malfunction
    Date Received
    November 14, 2022
    Date of Event
    August 17, 2022
    Report Date
    November 9, 2022
    Manufacturer
    ELITE BIOMEDICAL SOLUTIONS LLC
    Product Code
    MRZ
    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 A PUMP MODULE HAD A FREE FLOW EVENT. THERE WAS PATIENT INVOLVEMENT BUT PATIENT IMPACT IS UNKNOWN. BD INVESTIGATION WAS PERFORMED ON THE RETURNED SAMPLES, THE PROBABLE CAUSE OF THE COMPLAINT OF FREE FLOW WAS IDENTIFIED AS THE UNAUTHORIZED USE OF THIRD PARTY MANUFACTURED PARTS. THIRD PARTY PARTS WERE MANUFACTURED BY ELITE BIOMEDICAL SOLUTIONS (REAR CASE, BEZEL ASSEMBLY). FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2853175 ELITE BIOMEDICAL SOLUTIONS THIRD PARTY PARTS FOR PUMP ACCESSORIES, PUMP, INFUSION MRZ ELITE BIOMEDICAL SOLUTIONS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown