BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ALARIS PUMP MODULE SMARTSITE INFUSION SET

    MDR report key: 25179360 · Received May 14, 2026

    Report

    Report Number
    9616066-2026-01302
    Event Type
    Malfunction
    Date Received
    May 14, 2026
    Date of Event
    March 1, 2026
    Report Date
    May 11, 2026
    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
    NY, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    E.1. INITIAL REPORTER FACILITY NAME: (B)(6). H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ALARIS PUMP MODULE SMARTSITE INFUSION SET HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (B)(6) 2026 FAULTY PROXIMAL 2RY PORT IN PRIMARY TUBING LINE. LINE WAS CONNECTED TO PTS PICC W/CONTINUOUS HEPARIN RUNNING AND 2RY PORT W/ Y'D IN 2NDRY TUBING WAS NOT RUNNING. RN FOUND PT TO HAVE BLOOD BACKING UP INTO THE LINE. DISCONNECTED AND FLUSHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522819 BD ALARIS PUMP MODULE SMARTSITE INFUSION SET INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS S.A DE C.V. UNKNOWN 07613203021012

    Patients

    Seq Age Sex Outcome Treatment
    1