BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIFLO COMPANION ENTERAL NUTRITION PUMP

    MDR report key: 316993 · Received February 15, 2001

    Report

    Report Number
    1528738-2001-00005
    Event Type
    Malfunction
    Date Received
    February 15, 2001
    Date of Event
    January 11, 2001
    Report Date
    January 15, 2001
    Manufacturer
    ROSS PRODUCTS DIVISION/ABBOTT LABORATORIES
    Product Code
    LZH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    HOMECARE PT WAS BEING FED USING A PUMP. AN UNKNONW AMOUNT OF AN ENTERAL FEEDING SOLUTION WAS HUNG, AND THE PUMP WAS SET TO DELIVER 75ML/HR. 600 ML WERE DELIVERED IN 2 HOURS. PT'S FAMILY MEMBER HEARD PT'S CRIES AND SUCTIONED OFF 500 ML. REPORTER STATED SOME FLUID HAD ESCAPED THROUGH THE PT'S VENT. THERE WAS NO ILLNESS, INJURY OR MEDICAL INTERVENTION RESULTING FROM THE EVENT. ONE PT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5973 FLEXIFLO COMPANION ENTERAL NUTRITION PUMP 80 LZH PUMP, INFUSION, ENTERAL, EXTERNAL LZH ROSS PRODUCTS DIVISION/ABBOTT LABORATORIES 84 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Other VENTILATOR.