BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8100

    MDR report key: 2201502 · Received August 3, 2011

    Report

    Report Number
    2201502
    Event Type
    Malfunction
    Date Received
    August 3, 2011
    Date of Event
    July 27, 2011
    Report Date
    July 27, 2011
    Manufacturer
    ALARIS
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IV FLUIDS WERE STARTED ON THE PATIENT. THE PUMP CONTINUOUSLY ALARMED THAT AIR WAS IN LINE DESPITE THE FACT THERE WAS NO AIR IN THE LINE TIPS. IV FLUIDS WERE MOVED TO ANOTHER CHANNEL AND NO ADDITIONAL PROBLEMS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8100 INFUSION PUMP FRN ALARIS 8100AX01EE *

    Patients

    Seq Age Sex Outcome Treatment
    1 * NO OTHER THERAPIES