BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 22749980 · Received August 8, 2025

    Report

    Report Number
    2016493-2025-103643
    Event Type
    Malfunction
    Date Received
    August 8, 2025
    Date of Event
    July 15, 2025
    Report Date
    September 24, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403512667
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: SECTION IMDRF ANNEX A GRID, IMDRF ANNEX C GRID AND IMDRF ANNEX D GRID.

    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, 23-NOV-2009 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 NETWORK PORT WAS NOT FUNCTIONING BEHIND MEDSTATION. A FIELD SERVICE ENGINEER USED A LONGER NETWORK CABLE TO EXTEND ACROSS THE MEDICATION ROOM, SUCCESSFULLY RESTORED COMMUNICATION AND FULL SYNCHRONIZATION OF THE STATION. USER FROM THE PHARMACY REPORTED THE ISSUE TO HOSPITAL INFORMATION TECHNOLOGY FOR FURTHER INVESTIGATION, AS THE ORIGINAL NETWORK PORT WAS NOT FUNCTIONING. USERS ALSO MENTIONED THAT A POWER OUTAGE OCCURRED SEVERAL HOURS EARLIER, WHICH WAS LIKELY THE CAUSE OF THE NETWORK ISSUE. THE PHARMACY TEAM WOULD RELOCATE THE NETWORK CABLE TO ITS PROPER LOCATION ONCE THE PORT WAS REPAIRED. DIAGNOSTICS CONFIRMED THAT ALL SYSTEMS WERE FUNCTIONING CORRECTLY, AND THE RESULTS WERE SAVED IN C:\TEMP FOLDER. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE FIELD SERVICE ENGINEER TROUBLESHOT THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES, STATION WAS OFFLINE. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT THE BD PYXIS¿ MEDSTATION¿ ES, STATION WAS OFFLINE. 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
    227282 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002500 10885403512667

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown