BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ALARIS SMARTSITE EXTENSION SET

    MDR report key: 25167023 · Received May 14, 2026

    Report

    Report Number
    9616066-2026-01276
    Event Type
    Malfunction
    Date Received
    May 14, 2026
    Date of Event
    April 24, 2026
    Report Date
    April 28, 2026
    Manufacturer
    SISTEMAS MEDICOS ALARIS S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    07613203019248
    PMA / PMN Number
    K022209
    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

    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 BD ALARIS SMARTSITE EXTENSION SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY THE CUSTOMER THAT WHILE DOING MY SAFETY CHECKS BEFORE STARTING CARES, THEY NOTICED FLUID ON THE FLOOR UNDERNEATH THE BED, AND IT WAS VERY STICKY LIKE TPN. THEY SAW IT DRIPPING FROM THE END OF THE BED. AFTER TRACING MY LINES, THEY FOUND DROPS ON THE IV TUBING AND AROUND THE JUNCTION WHERE THE MED PORT ON THE IV PUMP INFUSION SET IS LOCATED. THEY SHOWED MY ACTION RN (B)(6) AND NOTIFIED THE NNP (B)(6). GRABBED A BLOOD GLUCOSE WHICH WAS 90 AND THE NNP ORDERED NEW FLUIDS TO HANG. THEY PLACED A STICKER WHERE THEY NOTICED THE LEAKING OCCURRING ON TO THE TUBING EXTENSION SET ITSELF, PLACED IT ALL IN A BAG AND PUT IT IN OUR MANAGER'S BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161279 BD ALARIS SMARTSITE EXTENSION SET INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS S.A. DE C.V. UNKNOWN 07613203019248

    Patients

    Seq Age Sex Outcome Treatment
    1