BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ALARIS PUMP MODULE SMARTSITE INFUSION SET

    MDR report key: 23284149 · Received October 15, 2025

    Report

    Report Number
    9616066-2025-03032
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Date of Event
    September 17, 2025
    Report Date
    November 25, 2025
    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
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. THE DATE OF EVENT IS UNKNOWN; BD AWARENESS DATE USED. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ALARIS PUMP MODULE SMARTSITE INFUSION SET HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THEY ARE EXPERIENCING A LARGE NUMBER OF OCCLUSION ALARMS. FOR PUMP YOU HAVE HIGHEST THRESHOLD AS SETTING, HOWEVER IF IN PUMP MODE, THE PUMP WILL ADJUST THE OCCLUSION PRESSURE BASED ON THE RATE OF INFUSION. THIS ALLOWS PROMPT ATTENTION FOR OCCLUSIONS RELATED TO LOW RATE. WITH NEW SOFTWARE, INFUSIONS UNDER 1ML/HR AUTO ADJUST TO 50MMHG ON PUMP. SINCE OXYTOCIN INITIATES AT 2ML/HR IT¿S POSSIBLE THE PUMP IS DECREASING THE OCCLUSION THRESHOLD TO ACCOMMODATE FOR THAT LOW RATE OF INFUSION. IF YOU WANT TO TEST THIS, SET INFUSION AT 999 AND NOTE TIC MARK ON PRESSURE DISPLAY, THEN CHANGE TO 50 ML/HR AND SEE TIC MARK MOVE. THE NURSE CAN ACCESS PUMP OPTIONS AND USE SELECTABLE PRESSURE OPTION TO ADJUST PRESSURE THRESHOLD. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER: WHAT WAS THE DATE AND TIME OF THE EVENT? THIS SEEMS TO BE AN OGOING PROBLEM AND NOT AN ISOLATED INCIDENT SO I DON'T HAVE A DATE AND TIME CAPTURE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178397 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