BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 24342217 · Received February 16, 2026

    Report

    Report Number
    2016493-2026-06581
    Event Type
    Malfunction
    Date Received
    February 16, 2026
    Date of Event
    January 19, 2026
    Report Date
    January 28, 2026
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403533228
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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, 23-JUN-2014 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 PYXIS DID NOT SHOW THE PATIENT'S NAME. A TECHNICAL SUPPORT SPECIALIST (TSS) INVESTIGATION CONFIRMED THAT THE STATION [CUS MJ/(B)(6)] HAS AN INACTIVITY THRESHOLD OF 30 DAYS, AS SHOWN IN THE CONFIGURATION SCREENSHOT. THE PATIENT WITH ORDERID 330545091 HAD NO ACTIVITY RECORDED AFTER THE LAST TRANSACTION. THEREFORE, WHEN THE USER ATTEMPTED TO LOCATE THE PATIENT, THE RECORD WAS NO LONGER AVAILABLE BECAUSE THE SYSTEM AUTOMATICALLY REMOVED THE PATIENT AFTER EXCEEDING THE 30 DAY INACTIVITY LIMIT. THIS BEHAVIOR ALIGNS WITH THE CURRENT PYXIS ENTERPRISE SERVER (PES) SETTINGS AND IS CONSISTENT WITH KNOWN FUNCTIONALITY SINCE GO LIVE, AS THE STATION SHARES THE SAME CONFIGURATION USED BY THE HOSPITAL. THIS EXPLAINS WHY THE PATIENT DETAILS WERE NOT VISIBLE DURING THE USER SEARCH. THE SYSTEM FUNCTIONED AFTER THE TECHNICAL SUPPORT SPECIALIST INVESTIGATED THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES, THE REGISTERED NURSE ATTEMPTED TO REMOVE A SUBLOCADE INJECTION FROM PYXIS. THE ORDER HAD ALREADY BEEN VERIFIED WITH AN ACTIVE START TIME. WHEN THE NURSE ATTEMPTED TO PULL THE MEDICATION, THE PATIENTS NAME DID NOT APPEAR IN PYXIS. THE CUSTOMER STATED THAT THIS MALFUNCTION OCCURRED WHILE DISPENSING THE MEDICATION AND CAUSED A DELAY TO THE 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
    403537 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002500 10885403533228

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown