BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 24065875 · Received January 14, 2026

    Report

    Report Number
    2016493-2025-149032
    Event Type
    Malfunction
    Date Received
    January 14, 2026
    Date of Event
    December 21, 2025
    Report Date
    April 2, 2026
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403533228
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION H IMDRF ANNEX CODES UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT, IT WAS DETERMINED THAT THE MULTI COMPONENT MEDICATION, AND THE SUBCOMPONENT WERE COMBINED INSTEAD OF REMAINING SEPARATE. A TECHNICAL SUPPORT SPECIALIST (TSS) ASKED THE CUSTOMER TO VERIFY WHETHER A SPECIFIC CONFIGURATION SETTING (ALLOW PARTIAL MULTI COMPONENT ORDER REMOVE) WAS ENABLED, BUT THE CUSTOMER STATED THEY WERE NOT AUTHORIZED TO ACCESS THE SERVER AND DID NOT HAVE THE PASSWORD. THE TSS CONFIRMED THAT THE FEATURE HAD PREVIOUSLY WORKED CORRECTLY, INCLUDING PROPER INTERFACE FUNCTIONALITY, CORRECT MULTI MED DISPLAY, AND THE ABILITY TO DELETE UNWANTED SUBCOMPONENTS. RECENTLY, THE MULTI COMPONENT MEDICATION DISPLAY BECAME INCORRECT, AND USERS WERE UNABLE TO REMOVE SUBCOMPONENTS. MULTIPLE POSSIBLE CAUSES WERE SHARED BASED ON KNOWLEDGE ARTICLE (KA) MULTI COMPONENT ORDER TROUBLESHOOTING, AND THE CUSTOMER CONFIRMED THERE WAS NO RESEND AND THAT ALL MULTI COMPONENT ORDERS WERE AFFECTED. THE ISSUE WAS SUSPECTED TO BE RELATED TO THE ORDER MESSAGE FORMAT FOR MULTI COMPONENT ORDERS. THE CASE WAS CIRCULATED TO THE BD INTERFACE ENGINEER TO VERIFY WHETHER ANY INTERFACE CHANGES OCCURRED, AND THE TSS PLANNED TO REASSIGN THE CASE TO INTEGRATION ENGINEERING SUPPORT TEAM (IEST) TO REVIEW ORDER CONFIGURATION. SAMPLE ORDERS WERE REVIEWED AND FOUND TO DISPLAY CORRECTLY ON THE ES SERVER, PATIENT ENCOUNTER SYSTEM (PES), AND CAREFUSION COORDINATION ENGINE (CCE), WITH NO INTERFACE OR CCE ISSUES IDENTIFIED. THE CASE WAS ESCALATED BACK TO TSC FOR STATION LEVEL INVESTIGATION, A SAMPLE ORDER WAS SAVED IN EPHI, AND NO FURTHER UPDATES WERE RECEIVED FROM THE CUSTOMER AFTERWARD. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST TROUBLESHOOTS THE DEVICE.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION H IMDRF ANNEX CODES. 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, 21-JUN-2010 AND CONFIRMED THAT THIS DEVICE WAS NOT PREVIOUSLY RETURNED FOR SERVICING AND THERE WERE NO PRODUCTION FAILURES WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. NO FINDINGS AVAILABLE AT THE TIME THIS REPORT WAS SUBMITTED; THEREFORE, ANNEX A CODE A27 WAS APPLIED. A SUPPLEMENTAL REPORT SHALL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE REFLECTING THE APPROPRIATE MEDICAL DEVICE PROBLEM ANNEX A CODE

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES, THE SUBCOMPONENT MEDICATION WAS DISPLAYED AS COMBINED INSTEAD OF SEPARATE. EACH SUBCOMPONENT SHOULD BE SHOWN INDIVIDUALLY SO THAT THE USER CAN CHOOSE TO DELETE ANY SPECIFIC SUBCOMPONENT THEY DO NOT WANT TO REMOVE OR DISPENSE. THE CUSTOMER REPORTED THAT THERE WAS A DELAY IN PATIENT CARE. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES, THE SUBCOMPONENT MEDICATION WAS DISPLAYED AS COMBINED INSTEAD OF SEPARATE. EACH SUBCOMPONENT SHOULD BE SHOWN INDIVIDUALLY SO THAT THE USER CAN CHOOSE TO DELETE ANY SPECIFIC SUBCOMPONENT THEY DO NOT WANT TO REMOVE OR DISPENSE. THE CUSTOMER REPORTED THAT THERE WAS A DELAY IN PATIENT CARE. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES, THE SUBCOMPONENT MEDICATION WAS DISPLAYED AS COMBINED INSTEAD OF SEPARATE. EACH SUBCOMPONENT SHOULD BE SHOWN INDIVIDUALLY SO THAT THE USER CAN CHOOSE TO DELETE ANY SPECIFIC SUBCOMPONENT THEY DO NOT WANT TO REMOVE OR DISPENSE. THE CUSTOMER REPORTED 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
    129492 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002500 10885403533228

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown