BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 22382088 · Received July 2, 2025

    Report

    Report Number
    2016493-2025-92461
    Event Type
    Malfunction
    Date Received
    July 2, 2025
    Date of Event
    June 6, 2025
    Report Date
    July 1, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403512667
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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, 23-MAR-2020 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 KEPT LOGGING OUT THE USERS WHEN PULLING MEDICATION. A TECHNICAL SUPPORT SPECIALIST (TSS) DIALED INTO THE STATION AND DISCOVERED THAT THE DATABASE SIZE HAD EXCEEDED THE THRESHOLD, REACHING OVER 11 GB. THE TSS USED A DATABASE CONSOLE COMMANDS SCRIPT TO SHRINK THE DATABASE, REDUCING ITS SIZE TO 10 GB. A REINDEXING SCRIPT WAS THEN RUN ON THE DSCLIENTOLTP DATABASE, WHICH FURTHER REDUCED THE SIZE TO 9984.01 MB. THE TSS BACKED UP THE DATABASE AND INITIATED A FULL SYNCHRONIZATION OF THE STATION. THE REINDEXING ULTIMATELY RESOLVED THE ISSUE. THE DATABASE SIZE WAS SUCCESSFULLY REDUCED TO 8.5 GB. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST TROUBLESHOT THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES, IT HAD A UNEXPECTED ERROR WHILE RECODING THIS TRANSACTION, NEED TO LOG OUT AND THE STATION KEEP LOG OUT THE USERS WHEN PULL MEDICATION. THE CUSTOMER REPORTED THAT ISSUE OCCURRED WHEN DISPENSING MEDICATIONS TO THE PATIENT. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1297426 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 323 10885403512667

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown