BEUDAMED
    FDA Adverse Event Other Summary report: N

    COMPAT ENTERAL DELIVERY SYSTEM

    MDR report key: 1056147 · Received June 3, 2008

    Report

    Report Number
    2110851-2008-00004
    Event Type
    Other
    Date Received
    June 3, 2008
    Date of Event
    May 5, 2008
    Report Date
    June 2, 2008
    Manufacturer
    NESTLE HEALTHCARE NUTRITION
    Product Code
    LZH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED FOR EVALUATION. PER THE USER FACILITY, THE DEVICE WORKED FINE.

    Description of Event or Problem · 1

    PHYSICIAN STATED THAT THE TUBE FROM THE FEEDING PUMP MAY HAVE BEEN PULLED OUT OF THE PUMP BY THE PT OR THE NURSE WHEN THE NURSE TURNED THE PT OVER AND ALL THE FORMULA GOT INTO THE PTS STOMACH (ABOUT 500CC) PHYSICIAN STATED THAT THE PT WAS OK, BUT WAS BURPING AND NAUSEOUS. THE DIRECTOR OF NURSING AT THE FACILITY STATED THAT THE INVESTIGATION RESULTS ARE THAT THE PT TAMPERED WITH AND REMOVED THE TUBING FROM THE PUMP. THE DIRECTOR OF NURSING STATED THAT THERE WAS NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPAT ENTERAL DELIVERY SYSTEM ENTERAL INFUSION PUMP LZH NESTLE HEALTHCARE NUTRITION 199235

    Patients

    Seq Age Sex Outcome Treatment
    1