BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPAT PUMP

    MDR report key: 290167 · Received August 10, 2000

    Report

    Report Number
    290167
    Event Type
    Injury
    Date Received
    August 10, 2000
    Date of Event
    August 3, 2000
    Report Date
    August 10, 2000
    Manufacturer
    NOVARTIS NUTRITION CORP
    Product Code
    LZH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    RESIDENT RECEIVED TUBE FEEDINGS. THEIR ORDER READS 1000CC OSMOLITE HNC 84CC/HR VIA CLOSED SYSTEM, DIVIDED INTO 4 FEEDINGS, AT 3 HOUR PERIODS. ALSO RECEIVES 420CC NSS FOR FLUSHES. RESIDENT RECEIVED 250CC IN EARLY AM BY 11-7 SHIFT. PUMP WAS THEN TURNED ON AT APPROXIMATELY 10AM TO INSTILL ANOTHER 250CC, AT 84GTTS/MIN. AT 1:31PM RESIDENT WAS NOTED TO BE VOMITING. IT WAS NOTED AT THIS TIME THAT 750CC WAS INSTILLED FROM 10AM, LEAVING THE BAG EMPTY. PUMP WAS CHECKED TO MAKE SURE THE PARAMETERS WERE SET CORRECTLY, AND WERE PROPERLY SET. AT 7PM RESIDENT TEMPERATURE INCREASED 100.9. PHYSICIAN WAS NOTIFIED OF BOTH EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPAT PUMP ENTERAL DELIVERY SYSTEM LZH NOVARTIS NUTRITION CORP 199235 *

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Life Threatening| R HAS RECEIVED ENTERAL FEEDINGS FROM THIS PARTICULAR| PUMP SINCE 03/21/2000.