BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ ANESTHESIA STATION ES

    MDR report key: 22089414 · Received May 27, 2025

    Report

    Report Number
    2016493-2025-83116
    Event Type
    Malfunction
    Date Received
    May 27, 2025
    Date of Event
    April 30, 2025
    Report Date
    May 26, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403477836
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 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, 08-OCT-2014 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 BIOMETRIC IDENTIFIER (BIO-ID) WAS NOT WORKING. A TECHNICAL SUPPORT SPECIALIST (TSS) REMOTELY ACCESSED THE SYSTEM, AND UNINSTALLED ALL EXISTING ENTRIES RELATED TO THE BIOMETRIC DRIVER. THE TSS THEN FOLLOWED A KNOWLEDGE ARTICLE TO INSTALL A SPECIFIC VERSION OF THE DRIVER. ALTHOUGH THE INSTALLATION WAS COMPLETED, ONLY 2 SOFTWARE DEVELOPMENT KIT (SDK) COMPONENTS WERE INSTALLED AND THEN TSS UNINSTALLED THE TWO SDKS AND LOCATED A DIFFERENT VERSION OF THE DRIVER. THIS VERSION WAS SUCCESSFULLY INSTALLED, INCLUDING ALL 5 REQUIRED COMPONENTS. THE SYSTEM WAS THEN RESTARTED TO COMPLETE THE INSTALLATION PROCESS. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT WHEN USING THE BD PYXIS¿ ANESTHESIA STATION ES, BIO ID WAS NOT WORKING. THE CUSTOMER STATED THAT THIS MALFUNCTION CAUSED A DELAY TO THE PATIENT CARE. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716015 BD PYXIS¿ ANESTHESIA STATION ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 327 10885403477836

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown