BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 24771259 · Received April 2, 2026

    Report

    Report Number
    2016493-2026-18754
    Event Type
    Malfunction
    Date Received
    April 2, 2026
    Date of Event
    March 6, 2026
    Report Date
    April 4, 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

    ADDITIONAL INFORMATION: SECTION H IMDRF ANNEX CODES. 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, 18-SEP-2019 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 A VULNERABILITY SCAN OF MHW 35CYSTO PAS.MHS.NET (10.4.40.64) CONFIRMED THAT PORT 445 WAS OPEN AND WAS USED FOR BOTH INBOUND AND OUTBOUND COMMUNICATION. A TECHNICAL SUPPORT SPECIALIST (TSS) COORDINATED A PYXIS DISASTER RECOVERY REBOOT, AFTER WHICH THE BD VENDOR REMOTELY ACCESSED THE PYXIS SYSTEM. THE TSS CONFIRMED THAT THE SYSTEM OPERATED ON WINDOWS 10 ENTERPRISE LONG TERM SERVICING CHANNEL 2019, WITH SERVER MESSAGE BLOCK (SMB) VERSION 2 IN USE AND VERSION 1 DISABLED. THE TSS VERIFIED THAT THE REQUIRED NETWORK DETAILS TO SUPPORT CONNECTIVITY FOR THE PYXIS APPLICATION AND SYSTEMS. THE TSS ALSO CONFIRMED THAT PATCH MANAGEMENT WAS HANDLED THROUGH A WINDOWS SERVER UPDATE SERVICES (WSUS) SERVER, WITH BD RESPONSIBLE FOR TESTING, DEPLOYING, AND APPLYING WINDOWS UPDATES TO THE DEVICES. ADDITIONALLY, THE TSS VERIFIED THAT ESET VERSION 11 ANTIVIRUS SOFTWARE WAS INSTALLED ON THE MACHINE. THE SYSTEM FUNCTIONED AS INTENDED AFTER TECHNICAL SUPPORT SPECIALIST TROUBLESHOT THE DEVICE.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES, RISK INVOLVING THIS DEVICE AND THE USAGE OF PORT 445. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES, RISK INVOLVING THIS DEVICE AND THE USAGE OF PORT 445. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829434 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002500 10885403533228

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown