BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 25065983 · Received May 4, 2026

    Report

    Report Number
    2016493-2026-25518
    Event Type
    Malfunction
    Date Received
    May 4, 2026
    Date of Event
    April 6, 2026
    Report Date
    April 8, 2026
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403533228
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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, 13-MAY-2021 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, A TECHNICAL SUPPORT SPECIALIST (TSS) DIALED INTO BOTH PT3-WEST AND PT3-EAST TO COMPARE SYSTEM TIMES AND CONFIRMED WHETHER PT3-WEST WAS ONE HOUR OFF OR IN AN OVERRIDE STATE; VERIFICATION SHOWED THAT PT3-WEST TIME MATCHED PT3-EAST WITH NO OVERRIDE INDICATED. THE TSS REVIEWED LOGS AND FOUND THAT STATION PT3-WEST HAD DOMAIN ERROR 2222. THEN THE CUSTOMER WAS INFORMED THAT SYSTEM TIME WAS CORRECT AND NO OVERRIDE WAS PRESENT. FURTHER THE TSS EXPLAINED THE CUSTOMER THAT THIS ERROR TYPICALLY OCCURS WHEN A STATION OR SERVER COULD NOT COMMUNICATE WITH THE CUSTOMER'S DOMAIN CONTROLLER. FOLLOW-UP EMAILS WERE SENT TO THE CUSTOMER WHETHER ISSUES PERSISTED; HOWEVER, NO RESPONSE WAS RECEIVED. AS NO FURTHER ISSUES WERE REPORTED, THE CASE WAS PROCEEDED TO CLOSURE. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST ASSESSED THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES, END USER COULD NOT LOGIN. THE CUSTOMER STATED THAT THERE WAS A DELAY IN PATIENT CARE. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413432 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002500 10885403533228

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown