BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SMARTSITE

    MDR report key: 25123073 · Received May 8, 2026

    Report

    Report Number
    9616066-2026-01232
    Event Type
    Malfunction
    Date Received
    May 8, 2026
    Date of Event
    April 17, 2026
    Report Date
    May 8, 2026
    Manufacturer
    SISTEMAS MEDICOS ALARIS S.A DE C.V.
    Product Code
    FPA
    UDI-DI
    10885403240942
    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. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. B3. THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER WAS ENTERED INTO THE DATE OF EVENT FIELD.

    Description of Event or Problem · 0

    IT IS REPORTED, ALARIS SMARTSITE ARE LEAKING, CHEMO HAD TO REMAKE THE MEDICATION, DUE TO A LEAK. ADDITIONAL INFORMATION: NO SERIOUS INJURIES NOTED, BUT HAD TO REMAKE CHEMO ON 3 SEPARATE OCCASIONS DUE TO LEAK CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT DD-MMM-YYYY? I DON'T HAVE SPECIFIC DATES, BUT NOTIFICATION DATES WERE AROUND 14/004/2026 - 16/004/2026.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416577 ALARIS SMARTSITE SET, ADMINISTRATION, INTRAVASCULAR FPA SISTEMAS MEDICOS ALARIS S.A DE C.V. 25045721 10885403240942

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown