BEUDAMED
    FDA Adverse Event Other Summary report: N

    COMPAT ENTERAL DELIVERY SYSTEM

    MDR report key: 1067898 · Received June 27, 2008

    Report

    Report Number
    2110851-2008-00005
    Event Type
    Other
    Date Received
    June 27, 2008
    Date of Event
    May 20, 2008
    Report Date
    June 27, 2008
    Manufacturer
    NESTLE HEALTHCARE NUTRITION
    Product Code
    LZH
    PMA / PMN Number
    K891575
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVIDENCE THAT DEVICE MALFUNCTIONED OR THAT ANY INJURY RESULTED FROM REPORTED EVENT. DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    REPORT RECEIVED ON MAY 29, 2008. FACILITY REPORTS THAT WHEN CHECKING ON PATIENT WHO WAS CONNECTED TO A FEEDING TUBE AND PUMP THAT THERE WAS FORMULA ON THE FLOOR, THE RESIDENTS FACE AND BACKING OUT OF THE TUBE FEEDING PORT. WHEN CHECKING THE PUMP, THE PUMP INDICATED THAT 482 CC HAD BEEN ADMINISTERED, HOWEVER THE 1000 CC BOTTLE OF FORMULA WAS EMPTY. FACILITY REPORTS THAT THE TUBE WAS CONNECTED PROPERLY TO THE PUMP AT THE TIME OF INCIDENT. FACILITY REPORTS THAT THERE WAS NO ADVERSE OUTCOMES RELATED TO THE PATIENT. THE FACILITY RISK MANAGER STATED THAT THERE WAS NO INJURY TO THE PATIENT. FACILITY REPORTS THAT DUE TO THE PUMP SHOWING 482 CC ADMINISTERED, IT IS LIKELY THAT A MALFUNCTION OR STAFF ERROR LIKELY OCCURRED.

    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 Other