BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE 8100

    MDR report key: 1901046 · Received October 19, 2010

    Report

    Report Number
    1901046
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    July 20, 2010
    Report Date
    October 19, 2010
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US

    Narratives

    Description of Event or Problem · 1

    PROGRAMMED PUMP TO INFUSE ANTIBIOTIC OVER 30 MINUTES. RETURNED TO ROOM WHEN IV WAS BEEPING APPROX 10 MINUTES LATER AND FOUND ENTIRE ANTIBIOTIC DOSE HAD BEEN INFUSED. NOTIFIED PHARMACY FOR CONTRAINDICATIONS AND ALSO CALLED MD.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR