BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATROL

    MDR report key: 1211664 · Received October 20, 2008

    Report

    Report Number
    1211664
    Event Type
    Malfunction
    Date Received
    October 20, 2008
    Date of Event
    October 12, 2008
    Report Date
    October 20, 2008
    Manufacturer
    ABBOTT NUTRITION
    Product Code
    LZH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US

    Narratives

    Description of Event or Problem · 1

    PATIENT RECEIVING TUBE FEEDING VIA A ROSS PATROL PUMP AT THE SAME TIME THAT SHE WAS RECEIVING AN INSULIN DRIP. THE PATIENT HAD A DROP IN HER BLOOD SUGAR AND REQUIRED AN INJECTION TO BOOST BLOOD SUGAR BACK UP. THE NURSING STAFF CHECKED THE FEEDING PUMP WHICH APPEARED TO NOT BE RUNNING, ALTHOUGH IT WAS NOT ALARMING. IT WAS UNCLEAR AT TIME OF REPORT EXACTLY WHAT HAPPENED WITH THE MACHINE. RN DID STATE WHILE TROUBLE SHOOTING PROBLEM THE PUMP DID FLASH "LOW BATTERY" BUT STILL DID NOT ALARM. THE PATIENT IS STILL AN INPATIENT ON THE BURN UNIT AND BLOOD SUGARS DID STABILIZE. THE FEEDING PUMP WAS SEQUESTERED. THIS IS A LEASED PIECE OF EQUIPMENT SO IT WILL BE RETURNED TO VENDOR FOR EVALUATION PURPOSES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR