BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATROL PUMP

    MDR report key: 2202275 · Received August 5, 2011

    Report

    Report Number
    1527460-2011-00056
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 8, 2011
    Manufacturer
    ABBOTT NUTRITION
    Product Code
    LZH
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    DIETICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) THE DEVICE REPORTED, LIST NUMBER 52034, IS AN ABBOTT PRODUCT THAT IS MARKETED INTERNATIONALLY WHICH IS THE SAME OR SIMILAR TO A DEVICE, LIST NUMBER 52036, THAT IS MARKETED DOMESTICALLY. ABBOTT NUTRITION STANDARD PROCEDURE INCLUDES ATTEMPTING TO OBTAIN ALL REQUIRED INFO FROM THE SOURCE.

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED AN OVER-DELIVERY. THE FEEDING AMOUNT HUNG WAS 1500ML AT A SET RATE OF 30ML/HR TO BE DELIVERED OVER 24 HRS, WHICH WOULD TOTAL 720ML OF FEED. HOWEVER, THE ACTUAL AMOUNT DELIVERED WAS 1200ML IN 12 HRS PER VISUAL ASSESSMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PATROL PUMP LZH, PUMP, INFUSION, ENTERAL LZH ABBOTT NUTRITION 52034

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR