BEUDAMED
    FDA Adverse Event Death Summary report: N

    COMPAT ENTERAL DELIVERY SYSTEM

    MDR report key: 1368826 · Received December 26, 2008

    Report

    Report Number
    2110851-2008-00006
    Event Type
    Death
    Date Received
    December 26, 2008
    Date of Event
    December 3, 2008
    Report Date
    December 17, 2008
    Manufacturer
    NESTLE HEALTHCARE NUTRITION, INC.
    Product Code
    LZH
    PMA / PMN Number
    K940555
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT DESCRIBING RESULTS FROM DEVICE TESTING ARE ATTACHED. PRODUCT AS RETURNED AND TESTED FUNCTIONED PROPERLY AND MEETS ALL PERFORMANCE SPECIFICATION. ADDITIONAL TEXT FROM THE IMPORTER REPORT: NESTLE, COMPAT ENTERAL DELIVERY SYSTEM. BECOME AWARE: 12/2/08, DATE OF REPORT: 2009 FOR LATE 2008.

    Description of Event or Problem · 1

    PT RECEIVED APPROXIMATELY 900CC OF FORMULA WITHIN 3.5 HOURS. PT WAS RECEIVING DIABETISOURCE AC. PUMP WAS SET AT 45CC/HOUR, 1/4 STRENGTH WATER WAS SET AT 150CC FOR 4 HOURS. NURSE HUNG BOTTLE AT 6:00 P.M., WENT INTO ROOM AT 9:30 AND BOTTLE ONLY HAD 100CC LEFT IN BOTTLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPAT ENTERAL DELIVERY SYSTEM ENTERAL INFUSION PUMP LZH NESTLE HEALTHCARE NUTRITION, INC. 199255

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Death| H