BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FG 6301 DUAL CHNL VOL INF PUMP2M8064 SERVICE

    MDR report key: 1000209 · Received February 19, 2008

    Report

    Report Number
    6000001-2008-00057
    Event Type
    Injury
    Date Received
    February 19, 2008
    Date of Event
    January 9, 2008
    Report Date
    January 30, 2008
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD
    Product Code
    FRN
    PMA / PMN Number
    K915523
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RECEIVED IN THE BAXTER SERVICE SHOP. IT HAS BEEN REQUESTED TO GO TO THE PRODUCT ANALYSIS LAB (PAL). A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    A MALE PATIENT WITH AN ADMITTING DIAGNOSIS OF RESPIRATORY DISTRESS, WAS BEING INFUSED WITH PROPOFOL 1000 MG/100 ML WHILE BEING VENTILATED AND IT OVERINFUSED. THE RATE WAS SET AT 7CC/HOUR. REPORTEDLY, NEW BOTTLE OF PROPOFOL AND TUBING WAS STARTED AT 1930 HOURS. AT 2000 HOURS, THE NURSE NOTICED THE PATIENT WAS NOT AS AWAKE AS HE PREVIOUSLY WAS. THE FLOW RATE WAS DECREASED TO 4CC/HOUR. AT 2015-2030 HOURS, THE BOTTLE WAS ALMOST EMPTY (APPROXIMATELY 90%). THE MEDICAL TEAM STOPPED THE PROPOFOL INFUSION AND CALLED THE PHYSICIAN. THE PATIENT'S VITALS WERE NOTED TO BE NORMAL AND THE DOCTOR CLEARED THE PATIENT FROM ANY INJURIES. THE PATIENT WAS NOT ABLE TO BE AWAKENED UNTIL TWO HOURS LATER. THE NURSE (AND STAFF) NOTED TWO CONCERNS WITH THE PUMP: THE ANNUAL SERVICE WAS DUE ON AUGUST 2007 AND IT HAD NOT BEEN CHECKED OFF AS BEING DONE, AND THE PUMP APPEARS TO REQUIRE A LOT OF FORCE WHEN PULLING THE TUBING OUT OF THE PUMP, SPECIFICALLY AROUND THE SAFETY SLIDE CLAMP LOCATION. NO NARCAN WAS GIVEN TO THE PATIENT. THE PATIENT HAS RECOVERED WELL AND HAS BEEN DISCHARGED FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FG 6301 DUAL CHNL VOL INF PUMP2M8064 SERVICE 80FRN FRN BAXTER HEALTHCARE PTE. LTD NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention THE PT WAS ON A VENTILATOR DURING THE INCIDENT