BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 23936376 · Received December 31, 2025

    Report

    Report Number
    2016493-2025-147011
    Event Type
    Malfunction
    Date Received
    December 31, 2025
    Date of Event
    December 19, 2025
    Report Date
    December 24, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403533228
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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, 27-SEP-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, IT WAS DETERMINED THAT DRAWER 2 HAD FAILED TO OPEN. A FIELD SERVICE ENGINEER (FSE) ADDRESSED AN ISSUE WHERE THE STATION DISPLAYED A "FAILED DRAWER 2 FULL HEIGHT CUBIE DRAWER, FAILED TO CLOSE" ERROR. INSPECTION REVEALED A MISSING LATCH INSEPARABLE MAGNET. THE STATION WAS POWERED DOWN, AND THE DRAWER WAS DISASSEMBLED FOLLOWING FSG SECTION 3.11.2 INSTRUCTIONS. THE INSEPARABLE LATCH WAS REPLACED, AND WHILE THE DRAWER WAS DISASSEMBLED, THE RETRACTOR BAND CABLE WAS RE-SEATED AT BOTH THE DRAWER AND MODULE CONTROLLER. THE ROW BOARD CABLE WAS ALSO RE-SEATED AT THE DRAWER CONTROLLER AND INDIVIDUAL ROW BOARDS. AFTER REASSEMBLY AND POWERING ON, DRAWER FUNCTIONALITY WAS VERIFIED IN DIAGNOSTICS. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE FIELD SERVICE ENGINEER REPAIRED THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES FULL HEIGHT DRAWER 2 WAS FAILED TO OPEN AND MEDICATIONS CANNOT BE PULLED FROM THE DRAWER. THE CUSTOMER STATED THAT THIS MALFUNCTION OCCURRED WHILE DISPENSING THE MEDICATION WHICH 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
    2529678 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002500 10885403533228

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown