BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 25047614 · Received April 30, 2026

    Report

    Report Number
    2016493-2026-25334
    Event Type
    Malfunction
    Date Received
    April 30, 2026
    Date of Event
    April 4, 2026
    Report Date
    April 9, 2026
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403533228
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE COMPLAINT HISTORY FOR (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 (B)(6) WAS PERFORMED FROM THE DATE OF MANUFACTURE, 26-APR-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 THE FATAL ERROR APPEARED INDICATING AN ISSUE WITH THE UNDERLYING DATA SOURCE, NETWORK CONNECTION, OR HARDWARE. A TECHNICAL SUPPORT SPECIALIST DIALED INTO THE STATION AND FOUND THE ERROR 'DSCLIENTOLTP IS FULL DUE TO LOG_BACKUP.' INVESTIGATION REVEALED THAT THE STRUCTURED QUERY LANGUAGE (SQL) RECOVERY MODEL WAS SET TO FULL. APPLIED KA(ES 1.6.1 DSCLIENTOLTP LOG FILE KEEP GROWING RECOVERY MODEL SET TO FULL) AND CHANGED THE RECOVERY MODEL TO SIMPLE. VERIFIED THAT THE ISSUE WAS RESOLVED. 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 4WA FATAL ERROR OCCURRED, INDICATING A POTENTIAL ISSUE WITH THE UNDERLYING DATA SOURCE, NETWORK CONNECTION, OR HARDWARE. THE CUSTOMER STATED THAT THERE WAS A DELAY IN PATIENT CARE. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326313 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002500 10885403533228

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown