BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CAREFUSION ALARIS PUMP

    MDR report key: 8785070 · Received July 11, 2019

    Report

    Report Number
    MW5088036
    Event Type
    Malfunction
    Date Received
    July 11, 2019
    Date of Event
    May 20, 2019
    Report Date
    July 9, 2019
    Manufacturer
    BD / CAREFUSION 303, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UT, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    BD / ALARIS SYRINGE PUMP VOLUME INFUSION DOCUMENTATION DISCREPANCY ISSUE RELATED TO INTEROPERABILITY. BD PUMP SENT INACCURATELY LARGE VOLUME THROUGH INTEROPERABILITY TO THE EHR. PT RECEIVED CORRECT VOLUME AND THERE WAS NO PT HARM. PT WAS AT RISK OF HARM DUE TO CLINICAL DECISION MAKING RELATED TO THE INACCURATE DATA. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577215 BD CAREFUSION ALARIS PUMP PUMP, INFUSION FRN BD / CAREFUSION 303, INC. 8110

    Patients

    Seq Age Sex Outcome Treatment
    1 3 DA Other