BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 21729826 · Received March 31, 2025

    Report

    Report Number
    2016493-2025-69813
    Event Type
    Malfunction
    Date Received
    March 31, 2025
    Date of Event
    March 4, 2025
    Report Date
    November 18, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403533228
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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. (B)(6).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION H IMDRF ANNEX CODES CORRECTION: SECTION D UNIQUE IDENTIFIER (UDI), SECTION H DEVICE MANUFACTURE DATE. A REVIEW OF THE COMPLAINT HISTORY FOR SN (B)(6) WAS PERFORMED IN SALESFORCE WHICH DID NOT LOCATE SIMILAR COMPLAINTS 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, 08-JAN-2018 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 ERROR: INVALID USER & PASSWORD. A TECHNICAL SUPPORT SPECIALIST (TSS) CONFIRMED THAT USER Q427506 WAS AFFECTED BY AN ISSUE IN ES 1.7.4, WHERE BOTH AN ACTIVE DIRECTORY AND A LOCAL USER ACCOUNT EXISTED ON THE ES SERVER WITH THE SAME USER IDENTIFIER. THE LOCAL ACCOUNT WAS MARKED AS INACTIVE, AND THAT WAS THE ACCOUNT THE SYSTEM ATTEMPTED TO USE DURING LOGIN. THE TSS INDICATED THAT DELETING THE LOCAL ACCOUNT SHOULD RESOLVE THE ISSUE. THE TSS ALSO LOOKED INTO THE OTHER THREE USERS AND FOUND THAT AT LEAST TWO OF THEM (K974552 AND X586600) HAD ALREADY RESET THEIR PASSWORDS AND ALLOWED USER TO SUCCESSFULLY LOG IN. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST INVESTIGATED THE ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES, THE USER HAD AN ACCESS ISSUE, INVALID USER & PASSWORD. THE CUSTOMER REPORTED THAT ISSUE OCCURRED WHEN DISPENSING MEDICATIONS. 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, THE USER HAD AN ACCESS ISSUE, INVALID USER & PASSWORD. THE CUSTOMER STATED THAT THIS MALFUNCTION OCCURRED WHILE DISPENSING THE MEDICATION TO A PATIENT. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    953934 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 323 10885403533228

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown