BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ ANESTHESIA STATION ES

    MDR report key: 25173856 · Received May 14, 2026

    Report

    Report Number
    2016493-2026-29237
    Event Type
    Malfunction
    Date Received
    May 14, 2026
    Date of Event
    April 19, 2026
    Report Date
    April 30, 2026
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403533242
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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, 27-MAY-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 THE STATION CACHED FORMULARY DATA WAS CORRUPTED. THE TECHNICAL SUPPORT SPECIALIST (TSS) PERFORMED BACKUP AND FULL SYNCHRONIZATION (NO DATABASE DROP), VERIFIED DATA SYNC COMMUNICATION, REBOOTED STATION, AND CONFIRMED NORMAL OPERATION. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST (TSS) RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ ANESTHESIA STATION ES DEXMEDETOMIDINE 4 MCG/ML NACL 0.9% SOLN 200 MCG/50 ML (MEDID 100597) DISPLAYED INCORRECTLY AS 2 ML VIALS (MEDID 100596) DURING ASSIGN AND LOAD, DESPITE CORRECT PRODUCT LINKAGE IN BARCODE MANAGEMENT, REQUIRING A FULL SYNC WITHOUT DB DROP. HOWEVER, THERE WERE NO DELAYS OR ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547822 BD PYXIS¿ ANESTHESIA STATION ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500400001500 10885403533242

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown