BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 25148171 · Received May 12, 2026

    Report

    Report Number
    2016493-2026-28132
    Event Type
    Malfunction
    Date Received
    May 12, 2026
    Date of Event
    April 13, 2026
    Report Date
    April 14, 2026
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403533228
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 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, 31-DEC-2015 AND CONFIRMED THAT THIS DEVICE WAS NOT PREVIOUSLY RETURNED FOR SERVICING AND THERE WERE NO PRODUCTION FAILURES WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. A REVIEW OF THE DEVICE HISTORY RECORD FOR SN (B)(6) WAS PERFORMED FROM THE DATE OF MANUFACTURE, 25-SEP-2024 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 REMOTE MANAGER, TOWER, AUXILIARY AND MAIN NOT DETECTED ON THE BUS. A FIELD SERVICE ENGINEER FOUND THAT THE COMMUNICATION SLED CONTROLLER BOARD HAD NO LIGHT EMITTING DIODES (LEDS) AND REPLACED THE BOARD. AFTER REPLACEMENT, ALL COMPONENTS WERE DETECTED EXCEPT TOWER DOORS 5, 6, 7, AND 8. A DOOR CONTROLLER BOARD REPLACEMENT WAS REQUIRED. THE CONTROLLER BOARD WAS REPLACED DUE TO PHYSICAL DAMAGE AND CUSTOMER VERIFIED FUNCTIONALITY. LATER, TECHNICAL SUPPORT SPECIALIST (TSS) DIALED INTO THE STATION TO ADDRESS PERSISTENT DRAWER FAILURES, APPLIED THE KNOWLEDGE ARTICLE, CANNOT RECOVER TOWER DOORS 5-8 AFTER COMMSLED REPLACEMENT AND IDENTIFIED MISMATCHED DEVICE KEYS. DATABASE CORRECTION STEPS WERE PERFORMED, INCLUDING STOPPING SERVICES, BACKING UP AND UPDATING THE DATABASE, AND COMPLETING A FULL DATA SYNC. ALTHOUGH THE DATABASE WAS SUCCESSFULLY RESTORED BUT THE FAILED HARDWARE ICON REMAINED. AN ONSITE FSE VISIT WAS REQUIRED, AND A NEW CASE WAS CREATED TO ADDRESS THE DRAWER HARDWARE ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES, ALL TOWER DOORS, DRAWERS, AND POCKETS COULD NOT BE RECOVERED AND DID NOT OPEN. THE CUSTOMER REPORTED BEING UNABLE TO RETRIEVE ANY MEDICATIONS FROM THE PYXIS STATION. 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
    459282 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002500 10885403533228

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SN: (B)(6) LOCATION: 6C_SJH.