BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ALARIS PUMP MODULE SMARTSITE INFUSION SET

    MDR report key: 23796420 · Received December 12, 2025

    Report

    Report Number
    9616066-2025-03767
    Event Type
    Malfunction
    Date Received
    December 12, 2025
    Date of Event
    October 27, 2025
    Report Date
    January 29, 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
    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.

    Additional Manufacturer Narrative · 0

    ONE SAMPLE MODEL 2420-0007 LOT 25075647 WAS RETURNED FOR INVESTIGATION. THE SET WAS EXAMINED FOR DEFECTS AND ABNORMALITIES. FOREIGN MATTER WAS SEEN ON THE INSIDE OF THE SPIKE CAP. NO OTHER DEFECTS OR ABNORMALITIES WERE OBSERVED. A QUALITY NOTIFICATION WAS SENT TO THE SUPPLIER. NO RESPONSE WAS RECEIVED BY THE SUPPLIER. IF A RESPONSE IS RECEIVED. THE INVESTIGATION WILL BE REOPENED TO INCLUDE THE INFORMATION THEY PROVIDE. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ALARIS PUMP MODULE SMARTSITE INFUSION SET HAD FOREIGN MATTER IN THE FLUID PATHWAY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONTAMINANT LOCATED IN AN AREA THAT SHOULD BE STERILE AS INTRAVENOUS FLUIDS WILL BE ACCESSED USING THIS SPIKED END OF THE INFUSION TUBING. DESCRIPTION OF PRODUCT: GEM V/NV 20D 1CV 2SS DEHP-FREE 20EA/CA. LOT OR S/N: (B)(6). COMPLAINT NOTICED: PRIOR TO USE. PROBLEM FREQUENCY: 1ST TIME. PATIENT INJURY: NO. QTY AFFECTED: 1 EA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2769851 BD ALARIS PUMP MODULE SMARTSITE INFUSION SET INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS S.A DE C.V. 25075647 07613203021012

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown