BEUDAMED
    FDA Adverse Event Death Summary report: N

    FLEXIFLO III ENTERNAL NUTRITION PUMP

    MDR report key: 142522 · Received January 8, 1998

    Report

    Report Number
    1528738-1998-00001
    Event Type
    Death
    Date Received
    January 8, 1998
    Date of Event
    December 8, 1997
    Report Date
    December 8, 1997
    Manufacturer
    ROSS PRODUCTS DIVISION ABBOTT LABORATORIES
    Product Code
    LZH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE PT WAS BEING FED USING A PUMP. AN UNK AMOUNT OF ENTERAL FEEDING SOLUTION WAS HUNG, AND THE PUMP WAS SET TO DELIVER 25 ML/HR. ONE LITER WAS DELIVERED IN 1 HR. THE PT EXPIRED THE SAME EVENING. THE PT WAS LISTED AS DNR. THE FACILITY DID NOT KNOW IF THE OVERDELIVERY CONTRIBUTED TO THE EVENT OR NOT. ONE PT INVOLVED. NOTE: THE DATES GIVEN IN B2 AND B3 ARE APPROXIMATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXIFLO III ENTERNAL NUTRITION PUMP 80 LZH PUMP, INFUSION, ENTERAL, EXTERNAL LZH ROSS PRODUCTS DIVISION ABBOTT LABORATORIES 82 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Death NONE REPORTED