BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATROL PUMP

    MDR report key: 1991014 · Received February 10, 2011

    Report

    Report Number
    1527460-2011-00008
    Event Type
    Injury
    Date Received
    February 10, 2011
    Date of Event
    December 30, 2010
    Report Date
    January 11, 2011
    Manufacturer
    ABBOTT NUTRITION
    Product Code
    LZH
    PMA / PMN Number
    K943733
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE TESTING AND INVESTIGATION RESULTS INDICATED THE COMPLAINT FOR OVER-DELIVERY WAS NOT CONFIRMED. AN INVESTIGATION WAS CONDUCTED THAT INCLUDED VISUAL INSPECTION OF THE DEVICE, FUNCTIONAL INSPECTION/TESTS THAT INCLUDED ALARMS, AND A DELIVERY ACCURACY TEST IN WHICH THE PUMP DELIVERED AT -6.7% ACCURACY, WHICH IS WITHIN SPECIFICATION. ABBOTT NUTRITION STANDARD PROCEDURE INCLUDES ATTEMPTING TO OBTAIN ALL REQUIRED INFORMATION FROM THE SOURCE.

    Description of Event or Problem · 1

    SAME CASE AS 1527460-2011-00009. AT 8:30 PM, A NURSE'S AIDE REPORTED TO A NURSE THAT THE PATIENT WAS HAVING A PROBLEM WITH HIS BREATHING. THE NURSE WENT INTO HIS ROOM IMMEDIATELY AND OBSERVED HIM CONGESTED AND PALE. ACCORDING TO THE NURSE'S AIDE, SHE WENT IN THE PATIENT'S ROOM, AND THE TUBING WAS NOT HOOKED UP, JUST HANGING FREELY. THE MACHINE WAS STILL ON, BUT IT WAS NOT BEEPING. SHE OBSERVED THE FEEDING BAG WAS EMPTY. SHE CALLED HER RN SUPERVISOR, TURNED OFF THE FEEDING MACHINE, AND THEY STARTED SUCTIONING HIM ORALLY. THEY OBTAINED 150CC OF ORAL SECRETIONS AND 500CC OBTAINED BY ASPIRATING GT VIA A PISTON SYRINGE FROM HIS STOMACH, MOSTLY FEEDING. THE PATIENT WAS PLACED IN HIGH FOWLER'S POSITION AND VITAL SIGNS WERE MONITORED. THE PATIENT'S OXYGEN SATURATION LEVEL IMPROVED TO 94%, AND THE PATIENT WAS RESPONSIVE TO TACTILE STIMULI AND WAS ABLE TO OPEN HIS EYES WHEN CALLED. THE PHYSICIAN ORDERED THE PATIENT TO THE EMERGENCY ROOM FOR EVALUATION, AND THE PATIENT WAS ADMITTED TO THE HOSPITAL. HE WAS BEING TREATED FOR ASPIRATION PNEUMONIA AND WAS STILL IN THE HOSPITAL AT THE TIME OF THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PATROL PUMP LZH, PUMP, INFUSION, ENTERAL LZH ABBOTT NUTRITION 52036

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Hospitalization