BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ALARIS PUMP MODULE SMARTSITE INFUSION SET

    MDR report key: 24507878 · Received March 4, 2026

    Report

    Report Number
    9616066-2026-00573
    Event Type
    Malfunction
    Date Received
    March 4, 2026
    Date of Event
    February 7, 2026
    Report Date
    April 17, 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
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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 LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WANTED TO REPORT AN INCIDENT WE HAD WITH BD ALARIS PUMP INFUSION SET 2420-0007. ON (B)(6) 2026, A NURSE REPORTED THAT UPON SPIKING A BAG WITH THIS TUBING, AND THERE WAS SOME LEAKAGE. THE ITEM WAS BROUGHT BACK TO THE PHARMACY, AND UPON INVESTIGATION THERE WAS A LEAK APPEARING AT THE SAFETY CLAMP AREA. WE WERE GIVEN 2 LOTS THAT THIS TUBING COULD HAVE BEEN FROM: LOT 25105173 EXP 10/6/2028, LOT 25095848 EXP 9/25/2028.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573036 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 NA Unknown