BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 22114152 · Received May 30, 2025

    Report

    Report Number
    2016493-2025-84115
    Event Type
    Malfunction
    Date Received
    May 30, 2025
    Date of Event
    May 6, 2025
    Report Date
    May 28, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403512667
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE COMPLAINT HISTORY FOR SN (B)(6) WAS PERFORMED IN SALESFORCE WHICH DID NOT LOCATE SIMILAR COMPLAINT(S) WITH THE SAME FAILURE MODE FOR THIS SERIAL NUMBER. A REVIEW OF THE DEVICE HISTORY RECORD FOR SN (B)(6) WAS PERFORMED FROM THE DATE OF MANUFACTURE, 15-MAY-2019 AND CONFIRMED THAT THIS DEVICE WAS NOT PREVIOUSLY RETURNED FOR SERVICING AND THERE WERE NO PRODUCTION FAILURES WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT, IT WAS DETERMINED THAT THE CUSTOMER WAS UNABLE TO LOG IN. A TECHNICAL SUPPORT SPECIALIST (TSS) FOUND AN ERROR IN THE MED APP LOG INDICATING A LOGIN FAILURE FOR USER 'PYX-HMI2\CFNADMIN' DUE TO AN UNEXPECTED DATA ERROR. THE TSS ATTEMPTED TO RESTART SQL SERVICES BUT ENCOUNTERED AN ERROR. THE TSS THEN FOUND THE DSCLIENTOLTP DATABASE IN SUSPECT MODE IN SQL SERVER MANAGEMENT STUDIO (SSMS) AND RAN A REPAIR SCRIPT. AFTER REFRESHING THE DATABASE AND REBOOTING THE SYSTEM, A NEW ERROR APPEARED. THE TSS RAN ANOTHER REPAIR SCRIPT, BUT THE ISSUE PERSISTED. THE TSS PROCEEDED TO REPAIR AND RESYNC THE STATION, REPAIRED THE STATION, AND COMPLETED DATA SYNCHRONIZATION. AFTER REBOOTING THE DEVICE, THE TSS CONFIRMED THERE WERE NO ERRORS, AND THE CUSTOMER WAS ABLE TO LOG IN. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST TROUBLESHOT THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES SYSTEM ALL USERS WERE UNABLE TO LOGIN. THE CUSTOMER STATED THAT THIS MALFUNCTION CAUSED A DELAY IN DISPENSING MEDICATION TO PATIENTS. HOWEVER, THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27414 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 323 10885403512667

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown