BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ALARIS SMARTSITE PUMP INFUSION SET

    MDR report key: 24514909 · Received March 5, 2026

    Report

    Report Number
    9616066-2026-00584
    Event Type
    Malfunction
    Date Received
    March 5, 2026
    Date of Event
    February 9, 2026
    Report Date
    March 6, 2026
    Manufacturer
    SISTEMAS MEDICOS ALARIS S.A DE C.V.
    Product Code
    FPA
    UDI-DI
    10885403232343
    PMA / PMN Number
    K022209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: (D.4.) DEVICE EXPIRATION DATE; UDI. (H.4.) DEVICE MANUFACTURE DATE. INVESTIGATION RESULTS: DUE TO NO SAMPLE BEING RECEIVED, AN INVESTIGATION COULD NOT BE PERFORMED, AND A ROOT CAUSE COULD NOT BE DETERMINED. NO PRODUCT WILL BE RETURNED PER CUSTOMER. NO INVESTIGATION WAS PERFORMED.

    Additional Manufacturer Narrative · 0

    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

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ALARIS SMARTSITE PUMP INFUSION SET HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NURSE WAS PRIMING THE TUBING WHEN IT BEGAN TO LEAK FROM THE TOP OF THE FILTER, WHERE THERE IS A CIRCULAR WHITE AREA. THE MEDICATION PRIMED WAS NOT A CHEMO DRUG. COMPLAINT NOTICED: DURING / AFTER USE. PROBLEM FREQUENCY: 1ST TIME. CUSTOMER EXPOSURE: ONCOLOGY CLINIC. PATIENT INJURY: NO. QTY AFFECTED: 1 EA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576673 BD ALARIS SMARTSITE PUMP INFUSION SET INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS S.A DE C.V. 25105592 10885403232343

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown