BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 21816052 · Received April 10, 2025

    Report

    Report Number
    2016493-2025-72405
    Event Type
    Malfunction
    Date Received
    April 10, 2025
    Date of Event
    March 14, 2025
    Report Date
    June 17, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE
    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, 06-MAR-2023 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 ALL MEDSTATIONS HAD REQUIRED AUTOMATIC DAILY REBOOTS TO PREVENT MEDICATION LOGISTICS MANAGEMENT (MLM) PRINTER ISSUES. A TECHNICAL SUPPORT SPECIALIST (TSS) HAD LOGGED INTO THE STATION, CONFIRMED THAT POWER MANAGEMENT WAS ENABLED, AND RESOLVED THE ISSUE BY REBOOTING THE DEVICE. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE 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 BY THE CUSTOMER THAT A BD PYXIS¿ MEDSTATION¿ ES ALL MEDSTATIONS NEED TO BE AUTOMATICALLY REBOOTED ON A DAILY BASIS TO AVOID MLM PRINTER ISSUES. THE CUSTOMER REPORTED THAT THIS MALFUNCTION CAUSE DELAY IN DISPENSING THE MEDICATION. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS INCIDENT.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT A BD PYXIS¿ MEDSTATION¿ ES ALL MEDSTATIONS NEED TO BE AUTOMATICALLY REBOOTED ON A DAILY BASIS TO AVOID MLM PRINTER ISSUES. THE CUSTOMER REPORTED THAT THIS MALFUNCTION CAUSE DELAY IN DISPENSING THE MEDICATION. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1455067 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 323

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown