BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ ES SERVER

    MDR report key: 24380803 · Received February 18, 2026

    Report

    Report Number
    2016493-2026-07515
    Event Type
    Malfunction
    Date Received
    February 18, 2026
    Date of Event
    January 26, 2026
    Report Date
    January 30, 2026
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4: UNIQUE DEVICE IDENTIFIER (UDI) NOT AVAILABLE. 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 (B)(6) WAS PERFORMED FROM THE DATE OF MANUFACTURE, 02-JUN-2020 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 PATIENTS WERE NOT CROSSING. A TECHNICAL SUPPORT SPECIALIST (TSS) REVIEWED ALL DEVICE EVENT REPORTS AND THE LAST TRANSACTION, THEN CHECKED THE PATIENT PROFILE AND NOTED THAT THE PATIENT WAS LISTED AS ADMITTED LEAVE OF ABSENCE (LOA). THE TSS ALSO VERIFIED IN THE PATIENT CAST QUERY THAT THE PATIENT REMAINED IN LOA STATUS. THE TSS ADVISED THE CUSTOMER TO CONTACT THEIR HOSPITAL INTERFACE TEAM TO SEND AN A22 MESSAGE TO READMIT THE PATIENT FROM LOA. THE TSS EMAILED THE CUSTOMER A GUIDE AND INSTRUCTED THEM TO WORK WITH THEIR HOSPITAL INTERFACE TEAM TO SEND THE CORRECT HL7 MESSAGE. THE CUSTOMER LATER CONFIRMED THAT THE ISSUE WAS RESOLVED. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST ASSESSED THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ ES SERVER, THE PATIENT WAS NOT CROSSING OVER. THE CUSTOMER STATED THAT THIS MALFUNCTION CAUSED A DELAY IN DISPENSING MEDICATION TO PATIENTS. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443631 BD PYXIS¿ ES SERVER AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002501

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown