BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS MEDSTATION ES

    MDR report key: 21014937 · Received December 25, 2024

    Report

    Report Number
    2016493-2024-01304
    Event Type
    Malfunction
    Date Received
    December 25, 2024
    Date of Event
    November 29, 2024
    Report Date
    March 18, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHARMACIST
    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. CORRECTIONS AND OR ADDITIONAL INFORMATION HAS BEEN ADDED TO THE FOLLOWING SECTIONS D1, D5, G1, G2, G6, H2, H6, H11. 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 30-NOV-2022 TO 29-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 THAT ETL (EXTRACT, TRANSFORM, AND LOAD) WAS DELAYED. THE TECHNICAL SUPPORT SPECIALIST APPLIED KA 000016803 "MEDSTATION ES - ETL DELAY OVERNIGHT - ETL (EXTRACT, TRANSFORM, AND LOAD) SLOWS DOWN WHILE IN THE PURGE WINDOW" TO RESOLVE. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST TROUBLESHOOTED THE DEVICE.

    Additional Manufacturer Narrative · 0

    UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT IT WAS DETERMINED THAT THE THAT ETL (EXTRACT, TRANSFORM, AND LOAD) WAS DELAYED. THE TECHNICAL SUPPORT SPECIALIST APPLIED KA (B)(4) "MEDSTATION ES - ETL DELAY OVERNIGHT - ETL (EXTRACT, TRANSFORM, AND LOAD) SLOWS DOWN WHILE IN THE PURGE WINDOW" TO RESOLVE. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST TROUBLESHOOTED THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD PYXIS MEDSTATION ES SYSTEM ON THE FLOOR AND THE PYXIS REPORTS FROM THE MAIN CONSOLE ARE NOT COMMUNICATING. THE CUSTOMER ADDED THAT THEY WERE NOT ABLE TO RETRIEVE MEDICATION. HOWEVER, THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD PYXIS MEDSTATION ES SYSTEM ON THE FLOOR AND THE PYXIS REPORTS FROM THE MAIN CONSOLE ARE NOT COMMUNICATING. THE CUSTOMER ADDED THAT THEY WERE NOT ABLE TO RETRIEVE MEDICATION. HOWEVER, THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75537 BD PYXIS MEDSTATION ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 323

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown