BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 24978925 · Received April 24, 2026

    Report

    Report Number
    2016493-2026-23668
    Event Type
    Malfunction
    Date Received
    April 24, 2026
    Date of Event
    March 28, 2026
    Report Date
    March 31, 2026
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403533228
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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, 10-NOV-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 PATIENT WAS NOT CROSSING OVER. A TECHNICAL SUPPORT SPECIALIST DIALED INTO THE SERVER AND RESTARTED THE EXTERNAL MESSAGING SERVICE, NET.PIPE LISTENER ADAPTER, NET.TCP LISTENER ADAPTER, NET.TCP PORT SHARING SERVICE, AND WORLD WIDE WEB PUBLISHING SERVICE AS PER KA (MEDES: INTERFACE DELAYED/DOWN NOTICE). RAN A PATIENT CAST QUERY FOR THE AFFECTED PATIENT AND IDENTIFIED THAT THE PATIENT HAD TRANSITIONED TO LEAVE ON ABSENCE (LOA) STATUS. INTERFACE ENGINEER (IE) CONFIRMED THAT ONCE A PATIENT MOVES TO LOA STATUS, THE HOSPITAL INTERFACE MUST SEND AN A22 HL7 MESSAGE TO READMIT THE PATIENT FROM LOA. GUIDANCE WAS PROVIDED TO THE CUSTOMER VIA EMAIL, ADVISING THEM TO CONTACT THEIR HOSPITAL INTERFACE TEAM TO SEND THE CORRECT HL7 MESSAGE. 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¿ MEDSTATION¿ ES, EHLAKE1 1 PATIENT NOT CROSSING OVER. THE CUSTOMER STATED THAT THERE WAS A DELAY IN 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
    591289 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002500 10885403533228

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown