BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 22901015 · Received August 26, 2025

    Report

    Report Number
    2016493-2025-108372
    Event Type
    Malfunction
    Date Received
    August 26, 2025
    Date of Event
    August 1, 2025
    Report Date
    August 28, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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, 25-JUL-2022 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 STATION HAD AN UNEXPECTED OVERRIDE. A TECHNICAL SUPPORT SPECIALIST (TSS) DIALED INTO THE STATION AND FOUND AN 'ACCOUNTALREADYLOCKED' ERROR IN THE MED APPLICATION LOGS. THE TSS LOGGED INTO PES VIA THE SERVER AND CONFIRMED THAT THE USER ACCOUNT WAS ACTIVE AND NOT LOCKED. THEN, THE TSS RAN POWERSHELL AND FOUND THAT THE ACCOUNT HAD EXPIRED. THE TSS ADVISED THE CUSTOMER TO CONTACT THE HOSPITAL INFORMATION TECHNOLOGY TEAM (HIT) WITH THE FINDINGS TO UPDATE ACCOUNT EXPIRES TO 0. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST AND HIT TROUBLESHOT THE ISSUE.

    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 THE BD PYXIS¿ MEDSTATION¿ ES USER WAS UNABLE TO LOG INTO PYXIS DUE TO AN AUTHENTICATION ERROR. THE CUSTOMER STATED THAT THIS MALFUNCTION HAD CAUSED A DELAY IN DISPENSING MEDICATION TO PATIENTS. HOWEVER, NO ADVERSE EVENTS OR INJURIES WERE REPORTED IN RELATION TO THIS INCIDENT.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT THE BD PYXIS¿ MEDSTATION¿ ES USER WAS UNABLE TO LOG INTO PYXIS DUE TO AN AUTHENTICATION ERROR. THE CUSTOMER STATED THAT THIS MALFUNCTION HAD CAUSED A DELAY IN DISPENSING MEDICATION TO PATIENTS. HOWEVER, NO ADVERSE EVENTS OR INJURIES WERE REPORTED IN RELATION TO THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1312549 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002500

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown