BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIFLO COMPANION ENTERAL NUTRITION PUMP

    MDR report key: 205240 · Received January 5, 1999

    Report

    Report Number
    1528738-1999-00001
    Event Type
    Malfunction
    Date Received
    January 5, 1999
    Date of Event
    December 7, 1998
    Report Date
    December 7, 1998
    Manufacturer
    ABBOTT LABORATORIES/ROSS PRODUCTS DIVISION
    Product Code
    LZH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE FEEDING FORMULA USED IN THIS EVENT: 100 GRAMS OF PROPIMEX POWDER WITH 95 GRAMS OF ISOMIL POWDER MIXED IN A BLENDER FOR A FEW SECONDS WITH ABOUT 1 OUNCE OF WATER. THEN FILL TO 38 OUNCES AND BLEND FOR A FEW MORE SECONDS. NOTE: MIXING TOO MUCH CAN BREAK THE EMULSION AND CREATE A "MARSHMALLOW" TYPE FORMULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXIFLO COMPANION ENTERAL NUTRITION PUMP 80 LZH PUMP, INFUSION, ENTERAL, EXTERNAL LZH ABBOTT LABORATORIES/ROSS PRODUCTS DIVISION 84 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Other