BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ALARIS SMARTSITE PUMP INFUSION SET

    MDR report key: 23285994 · Received October 15, 2025

    Report

    Report Number
    9616066-2025-03043
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Date of Event
    August 31, 2025
    Report Date
    October 22, 2025
    Manufacturer
    SISTEMAS MEDICOS ALARIS S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    07613203021012
    PMA / PMN Number
    K221327
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    NO PRODUCT OR PHOTO WAS RETURNED BY THE CUSTOMER. THE CUSTOMER COMPLAINT OF FLOW ISSUES - ACCURACY COULD NOT BE VERIFIED DUE TO THE PRODUCT NOT BEING RETURNED FOR FAILURE INVESTIGATION. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED ON MATERIAL 2420-0007 BECAUSE THE LOT NUMBER IS UNKNOWN. DUE TO NO SAMPLE BEING RECEIVED, AN INVESTIGATION COULD NOT BE PERFORMED, AND A ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD ALARIS SMARTSITE PUMP INFUSION SET HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY THE CUSTOMER THAT IV CEFEPIME STARTED AT 0615 - CEFEPIME BAG COMPLETELY EMPTY AT 0815. VERIFIED PUMP SETTINGS AND IT WAS CORRECT AT 12.5ML/HR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2482895 BD ALARIS SMARTSITE PUMP INFUSION SET INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS S.A. DE C.V. UNKNOWN 07613203021012

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown