BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDFLEX 2000

    MDR report key: 23990784 · Received January 7, 2026

    Report

    Report Number
    2016493-2025-148058
    Event Type
    Malfunction
    Date Received
    January 7, 2026
    Date of Event
    December 23, 2025
    Report Date
    December 29, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403512704
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, 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, 22-SEP-2025 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 MATRIX DRAWER 04 WAS FAILED TO OPEN. A FIELD SERVICE ENGINEER RECONNECTED THE LOOSE PYXIBUS CABLE AT THE CONTROLLER BOARD FOR DRAWER 2, ZONE 4 AND VERIFIED THE CONNECTION VIA ZONE LOCATION. THE CUSTOMER SUCCESSFULLY REMOVED MEDICATION FROM THE DRAWER. 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¿ MEDFLEX 2000, THE USER WAS ATTEMPTED TO ISSUE BACTRIM DS 800MG/160MG TABLETS FROM DRAWER 04 (MATRIX DRAWER), BUT THE DRAWER DID NOT OPEN. HOWEVER, THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53108 BD PYXIS¿ MEDFLEX 2000 AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500004502000 10885403512704

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown