BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PYXIS MEDSTATION ES SYSTEM

    MDR report key: 21362628 · Received February 12, 2025

    Report

    Report Number
    2016493-2025-04136
    Event Type
    Malfunction
    Date Received
    February 12, 2025
    Date of Event
    January 14, 2025
    Report Date
    February 12, 2025
    Manufacturer
    CAREFUSION 303
    Product Code
    BRY
    UDI-DI
    10885403512667
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT, IT WAS DETERMINED THAT THE MALFUNCTION WAS CAUSED BY THE NETWORK AND COMMUNICATION ISSUE. THE TECHNICAL SUPPORT SPECIALIST JOINED MEETING AND SENT AN EMAIL TO CUSTOMER RESOLVING THE ISSUE. THE SYSTEM FUNCTIONED AS INTENDED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT A PYXIS MEDSTATION ES SYSTEM CONNECTION BETWEEN MOA,HI AND IB NOT BE ACTIVE FOR MORE THAN 60 MINUTES. THE CUSTOMER STATED THAT THERE WAS NO DELAY IN ACCESSING MEDICATION SINCE THEY MANGED TO GET THE MEDICINES FROM OTHER STATION. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847070 PYXIS MEDSTATION ES SYSTEM AUTOMATED DISPENSING CABINET BRY CAREFUSION 303 323 10885403512667

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown