BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ ANESTHESIA STATION ES

    MDR report key: 25233882 · Received May 20, 2026

    Report

    Report Number
    2016493-2026-30627
    Event Type
    Malfunction
    Date Received
    May 20, 2026
    Date of Event
    April 24, 2026
    Report Date
    April 29, 2026
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403533242
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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, 05-NOV-2022 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 DATABASE WAS BLOATED TO 9 GB. A TECHNICAL SUPPORT SPECIALIST (TSS) DIALED INTO THE STATION AND PERFORMED A MANUAL DATABASE SHRINK USING STRUCTURED QUERY LANGUAGE (SQL), WHICH REDUCED THE DATABASE SIZE TO 5.9 GB. IN ANOTHER CASE TSS PERFORMED A FULL SYNC WITH DATABASE DROP AND REPAIR, REDUCING THE ISSUE, AND DATA WAS CONFIRMED AS CURRENT WITH NO PENDING TRANSACTIONS. 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¿ ANESTHESIA STATION ES, CURRENT PATIENT PROFILES WERE NOT VISIBLE ON THE DEVICE, AND ONLY TEMPORARY PATIENTS APPEARED. NO ERROR MESSAGES WERE DISPLAYED. PATIENTS WERE VISIBLE IN GLOBAL PATIENT SEARCH (EPHI). THE CUSTOMER REBOOTED THE DEVICE; HOWEVER, THE ISSUE PERSISTED. 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
    560312 BD PYXIS¿ ANESTHESIA STATION ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500400001500 10885403533242

    Patients

    Seq Age Sex Outcome Treatment
    1