BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDFLEX 1000

    MDR report key: 24035210 · Received January 12, 2026

    Report

    Report Number
    2016493-2026-00176
    Event Type
    Malfunction
    Date Received
    January 12, 2026
    Date of Event
    June 24, 2025
    Report Date
    January 9, 2026
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403512704
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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, 16-SEP-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. UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT, IT WAS DETERMINED THAT THE MEDCART KEYS WERE LOCKED OUT. A TECHNICAL SUPPORT SPECIALIST REMOTED INTO THE CABINET AND OBSERVED THAT THE ITEM COULD NOT BE CYCLE COUNTED, WITH THE SYSTEM DISPLAYING A NOTIFY DON MESSAGE. THE ITEM ALSO COULD NOT BE ISSUED DUE TO A QOH OF ZERO. CUSTOMER WAS ADVISED TO CHECK WITH THE DON, AS SHE HAS FACILITY ADMIN ACCESS TO RESOLVE THE ISSUE. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST TROUBLESHOT THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDFLEX 1000 THE KEYS WERE LOCKED OUT BECAUSE THE ITEM WAS SHOWING 0 QOH, PREVENTING THE USER FROM ISSUING THE ITEM. THE CUSTOMER STATED THAT THIS MALFUNCTION OCCURRED WHILE DISPENSING THE MEDICATION. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99697 BD PYXIS¿ MEDFLEX 1000 AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500004502000 10885403512704

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown