BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ALARIS PUMP MODULE SMARTSITE INFUSION SET

    MDR report key: 18088581 · Received November 7, 2023

    Report

    Report Number
    9616066-2023-02165
    Event Type
    Malfunction
    Date Received
    November 7, 2023
    Date of Event
    September 23, 2023
    Report Date
    October 24, 2023
    Manufacturer
    SISTEMAS MEDICOS ALARIS S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    50885403232303
    PMA / PMN Number
    K944320
    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

    H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE INFUSION SET HAD AIR IN THE LINE, THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE VERBATIM: THANK SO MUCH FOR TAKING THE TIME TO TALK TO ME TODAY. AS PER OUR CONVERSATION: YOU HAVE A GENERALIZED COMPLAINT OF AIR-IN-LINE WITH THE IV SET 11522558 WHICH IS THE BD BALL/VALVE SET . THERE HAVE BEEN MULTIPLE INTERNAL REPORTS (UNKNOWN NUMBER OF EVENTS) OF THE BALL FAILING TO SEAT PROPERLY AND AIR GETTING DOWN INTO THE LINE. THERE IS NOT A LOT NUMBER AVAILABLE FOR THESE EVENTS AND THERE WAS NO PATIENT HARM RELATED TO THE AIR IN LINE. AN UNKNOWN NUMBER OF THESE EVENTS HAVE HAPPENED IN AN OUTPATIENT INFUSION CENTER. PLEASE CONFIRM THAT THIS INFORMATION REGARDING THE REPORTED ISSUE OF AIR IN LINE FROM BALL VALVE NOT SEATING PROPERLY IS ACCURATE AND THAT THERE IS NOT ANY OTHER INFORMATION AVAILABLE. ON PREVIOUS SITE VISITS, CPC DETERMINED THAT THE PRACTICE IN THE INFUSION CENTER OF OVER PROGRAMMING THE VTBI (VOLUME TO BE INFUSED) TO INCLUDE THE FLUSH WAS A CONTRIBUTING FACTOR TO THE FAILURE OF THE BALL SEATING PROPERLY. A VACUUM IS CREATED WHICH CAN POTENTIALLY PREVENT THE BALL FROM COMPLETELY SEALING THE VALVE. IF THERE IS A DEFORMITY IN THE DRIP CHAMBER THIS CAN ALSO LEAD TO THE BALL NOT SEATING PROPERLY. A POSSIBLE SOLUTION WOULD BE TO CHANGE TO THE SHORT SET CONNECTED TO A 3 PORT LONG PRIMARY SET TO DELIVER THE MEDICATIONS. THEY COULD INCLUDE THE FLUSH AS THEY LIKE TO, AND THEY WOULD INTENTIONALLY RUN THE MEDICATION TO THE AIR IN LINE SENSOR. THE PRIMARY LINE WOULD THEN BE USED TO FLUSH THE REST OF THE MEDICATION. I AM INCLUDING A LINK TO A VIDEO THAT SHOWS HOW THIS WORKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812851 BD ALARIS PUMP MODULE SMARTSITE INFUSION SET INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS S.A. DE C.V. UNKNOWN 50885403232303

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown