BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS

    MDR report key: 6607610 · Received June 2, 2017

    Report

    Report Number
    6607610
    Event Type
    Malfunction
    Date Received
    June 2, 2017
    Date of Event
    February 6, 2017
    Report Date
    May 17, 2017
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DIVERSION FROM A BAG OF FENTANYL 10 MCG/ML. AT 0500, APPROXIMATELY 100 ML OF FENTANYL WAS NOTED MISSING FROM THE BAG. MANUFACTURER RESPONSE FOR BD CAREFUSION ALARIS SYSTEM PUMP 8100, INFUSION PUMP, BD CAREFUSION (PER SITE REPORTER): THE INVESTIGATION REPORT FROM CAREFUSION STATED THEY COULD NOT CONFIRM THAT THE 100ML OF FENTANYL WAS REPORTED MISSING COULD NOT BE ASCERTAINED FROM THE BAG VOLUME. THE USER DID NOT ENTER A NEW VOLUME TO BE INFUSED (VTBI) WHEN THE INFUSION WAS STARTED. THE INFUSION WAS RUNNING AT THE REPORTED RATE OF 2.5 ML/H. THE VTBI WAS CHANGE FROM THE REMAINING VOLUME OF 75.128 ML TO 15 ML. THE REASON FOR THE VTBI CHANGE COULD NOT BE DETERMINED FROM THE LOG ANALYSIS. IT COULD NOT BE DETERMINED IF A DIVERSION FROM THE BAG OCCURRED AND BD WAS UNABLE TO DETERMINE A ROOT CAUSE FOR THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388921 ALARIS PUMP, INFUSION FRN CAREFUSION 303, INC. 8100

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR