BEUDAMED
    FDA Adverse Event Death Summary report: N

    ROSS EASY FEED ENTERAL NUTRITION BAG

    MDR report key: 436998 · Received December 27, 2002

    Report

    Report Number
    436998
    Event Type
    Death
    Date Received
    December 27, 2002
    Date of Event
    December 23, 2002
    Report Date
    December 27, 2002
    Manufacturer
    ABBOTT LABORATORIES, INC., ROSS PRODUCTS DIVISION
    Product Code
    FPD
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AFTER REVIEWING THE PREVIOUS REPORT RPTR REALIZED CLARIFICATION WAS NEEDED TO SPECIFY THAT UPON INSPECTION AT THE TIME OF INCIDENT, THE CLAMP IN QUESTION WAS NOT COMPLETELY DISENGAGED BUT INSTEAD, HAD ONLY PARTIALLY DISENGAGED. NONETHELESS, IT APPEARS THAT THE PT RECEIVED A HIGHER RATE OF TUBE FEEDING FORMULA THAN WAS PRESCRIBED.

    Description of Event or Problem · 1

    THE PT IN QUESTION WAS SET UP TO RECEIVE TUBE FEEDING FROM A "GRAVITY FEED" ENTERAL FEEDING DEVICE. AFTER SET-UP THE PT BEGAN RECEIVING THE FEEDING AT 65CC PER HOUR. STAFF CONTINUED TO MONITOR THE TUBE FEEDING APPARATUS INTERMITTENTLY WHICH APPEARED TO BE FUNCTIONING NORMALLY DURING THE FIRST TWO OBSERVATIONS. AT SOME TIME AFTER THE SECOND STAFF MONITORING, THE FLOW REGULATOR BECAME DISENGAGED AND TUBE FEEDING BEGAN TO BE DISPENSED AT A HIGHER THAN PRESCRIBED RATE. SUBSEQUENTLY, THE PT RECEIVED TOO MUCH TUBE FEEDING FORMULA AND APPEARS TO HAVE ASPIRATED TUBE FEEDING FORMULA. SHORTLY AFTER THIS INCIDENT, THE PT DEVELOPED RESPIRATORY DISTRESS AND WAS SENT BACK TO THE HOSP. THEY ARE CURRENTLY ON A VENTILATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROSS EASY FEED ENTERAL NUTRITION BAG ENTERAL FEEDING DEVICE - (GRAVITY FEED) FPD ABBOTT LABORATORIES, INC., ROSS PRODUCTS DIVISION 56 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death| H| L