BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURE

    MDR report key: 10501983 · Received September 8, 2020

    Report

    Report Number
    1937141-2020-00001
    Event Type
    Malfunction
    Date Received
    September 8, 2020
    Report Date
    September 8, 2020
    Manufacturer
    THE METRIX COMPANY
    Product Code
    KPE
    UDI-DI
    00812496011756
    PMA / PMN Number
    K030888
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE METRIX COMPANY RECEIVED A REPORT FROM A USER FACILITY REGRADING THE OCCURRENCE OF LEAK ON A 250 ML EVA BAG . THE LEAK WAS NOTED BY AN END USER. METRIX'S CUSTOMER SUPPLIED THE FOLLOWING DETAILS: "PT ON MILRINONE CONT. PT DAUGHTER VISITED TO CHANGE THE BAG AND REPORTED THAT PUMP WAS ALARMING AND BAG WAS EMPTY. THE POUCH WAS TOTALLY WET. PT DAUGHTER THINKS BAG WAS EMPTY FOR APPROX 3 HRS. THE BAG WAS 250ML EVA BAG 66045/A5338-FO LOT A4999 EXP 9/21. THE DAUGHTER THREW THE BAG OUT WHEN SHE CHANGED IT. THE PUMP WORKS FINE. PT IS FINE." AS THE END USER DISCARDED THE BAG, IT WAS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE LOT IN QUESTION SHOWS NO MANUFACTURING NOR QUALITY ISSUES. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FOR THE 250 ML EVA BAG. AT THIS TIME METRIX IS UNABLE TO CONFIRM WHETHER THE BAG ITSELF WAS LEAKING OR IF THE LEAK WAS RELATED TO THE ADMINISTRATION SET OR USER ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    966460 SECURE 250 ML EVA 2 PORT BAG KPE THE METRIX COMPANY 66405 66045-A4999 00812496011756

    Patients

    Seq Age Sex Outcome Treatment
    1