BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ ANESTHESIA STATION ES

    MDR report key: 21875334 · Received April 21, 2025

    Report

    Report Number
    2016493-2025-74850
    Event Type
    Malfunction
    Date Received
    April 21, 2025
    Date of Event
    March 26, 2025
    Report Date
    April 21, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403477836
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 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, 11-FEB-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 THERE WAS LOGIN ISSUE WITH THE USERNAME AND PASSWORD. THE TECHNICAL SUPPORT SPECIALIST DIALED INTO THE STATION, ANALYZED THE STATION MEDAPP LOG, AND TRACED THE ERROR. THEY CHECKED THAT THE ES SERVER ACCOUNT WAS ACTIVE AND NOT LOCKED, THEN RESTARTED THE AD SYNC SERVICE, THE PYXIS-IDENTITY-SERVER, AND THE PYXIS-IDENTITY APP POOL. THE SPECIALIST NOTIFIED THE CUSTOMER VIA EMAIL ABOUT THE FINDING AND SUGGESTED DISABLING THE 'EXEMPT FROM BIO ID' OPTION TO SKIP THE LOGIN USING USERNAME AND PASSWORD. THE CUSTOMER MENTIONED THAT THE BIO-ID OPTION WAS NOT APPLICABLE. THE SPECIALIST ADVISED THE CUSTOMER TO REACH OUT TO THE HEALTH INFORMATION TECHNOLOGY (HIT) TEAM TO RESET THE PASSWORD. THE ISSUE WAS RESOLVED, AND THE CUSTOMER STATED THE SYSTEM WAS WORKING NORMALLY. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST INVESTIGATED THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT A BD PYXIS¿ ANESTHESIA STATION ES THAT THERE WAS LOGIN ISSUE WITH THE USERNAME AND PASSWORD. THE CUSTOMER STATED THAT THIS MALFUNCTION CAUSED A DELAY IN DISPENSING MEDICATION TO PATIENTS. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1338985 BD PYXIS¿ ANESTHESIA STATION ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 327 10885403477836

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown