BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS MEDSTATION ES SYSTEM

    MDR report key: 20891057 · Received December 10, 2024

    Report

    Report Number
    2016493-2024-00985
    Event Type
    Malfunction
    Date Received
    December 10, 2024
    Date of Event
    November 14, 2024
    Report Date
    March 12, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403512667
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REGULATORY REPORT IS BEING SUBMITTED DUE TO A RETROSPECTIVE REVIEW CONDUCTED THROUGH CAPA 10308384. THE LATE SUBMISSION OF THIS SUPPLEMENTAL REPORT IS DUE TO THE THOROUGH AND DETAILED NATURE OF THE RETROSPECTIVE REVIEW PROCESS. THIS PROCESS WAS ESSENTIAL TO ACCURATELY CAPTURE ALL RELEVANT DATA AND ENSURE THE INTEGRITY OF OUR REPORTING. WE HAVE INCLUDED THE CAPA REFERENCE FOR THE RETROSPECTIVE REVIEW IN THE ADDITIONAL MANUFACTURER NARRATIVE SECTION OF THE FDA FORM 3500A, AS RECOMMENDED. 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 15-NOV-2022 TO 14-NOV-2024 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 ORDERS WERE NOT CROSSING FOR A UNIT. A TECHNICAL SUPPORT SPECIALIST CONFIRMED THAT THE ISSUE WAS WITH THE CUSTOMER'S EMR. THE SYSTEM FUNCTIONED AS INTENDED.

    Additional Manufacturer Narrative · 0

    UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT, IT WAS DETERMINED THAT THE ACTIVE DIRECTORY SERVERS WERE NOT WORKING PROPERLY. A TECHNICAL SUPPORT SPECIALIST CONFIRMED WITH CUSTOMER THAT THE ISSUE WAS NOT A SERVER ISSUE. THE ISSUE WAS WITH THE CUSTOMER'S ENVIRONMENT. THE SYSTEM FUNCTIONED AS INTENDED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT A BD PYXIS MEDSTATION ES SYSTEM ORDERS WERE NOT CROSSING FOR ONE UNIT. THE CUSTOMER REPORTED THAT THE PHARMACISTS WERE UNABLE TO SEE THE UNVERIFIED ORDERS WHEN PATIENTS WERE IN A TEMPORARY LOCATION, V-RAD-PROC. THIS RESULTED IN DELAYING PATIENT CARE. 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 PYXIS MEDSTATION ES SYSTEM ORDERS WERE NOT CROSSING FOR ONE UNIT. THE CUSTOMER REPORTED THAT THE PHARMACISTS WERE UNABLE TO SEE THE UNVERIFIED ORDERS WHEN PATIENTS WERE IN A TEMPORARY LOCATION, V-RAD-PROC. THIS RESULTED IN DELAYING PATIENT CARE. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1678528 BD PYXIS MEDSTATION ES SYSTEM AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 323 10885403512667

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown