BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ ANESTHESIA STATION ES

    MDR report key: 24257720 · Received February 4, 2026

    Report

    Report Number
    2016493-2026-04238
    Event Type
    Malfunction
    Date Received
    February 4, 2026
    Date of Event
    January 14, 2026
    Report Date
    January 20, 2026
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403533242
    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

    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-2017 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 OF THIS INCIDENT, IT WAS DETERMINED THAT THE DRAWER DID NOT OPEN PROPERLY. A FIELD SERVICE ENGINEER (FSE) REPLACED THE MINI ENGINE, BUT ADDITIONAL REPAIRS WERE POSTPONED PENDING PART 133456 03. LATER, FSE IT WAS IDENTIFIED THAT DRAWERS 1.8 AND 1.9 WERE MALFUNCTIONING. FSE DURING HARDWARE TEST APPLICATION (HTA) TESTING, THE HARDWARE FAILED TO FULLY EJECT, WITH THE MINI DRAWERS RELEASING ONLY A FEW CENTIMETERS BEFORE FAILING. FSE POWERED OFF THE STATION. BOTH MINI ENGINES FOR DRAWERS 1.8 AND 1.9 WERE REPLACED USING SITE PROVIDED UNITS. THE HARDWARE WAS REBOOTED, HTA WAS LAUNCHED, AND ALL HARDWARE TESTS COMPLETED SUCCESSFULLY. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE FIELD SERVICE ENGINEER REPAIRED THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ ANESTHESIA STATION ES, THE DRAWER FAILED AND THE PLASTIC COVERING HAD RIPPED OFF. THE DRAWER APPEARED TO HAVE AN OPENING ISSUE AS IT SHOULD AND WAS JAMMED OR STUCK WHEN TRYING TO PULL MEDICATION. THE CUSTOMER STATED THAT THIS MALFUNCTION OCCURRED WHILE DISPENSING THE MEDICATION AND CAUSED A DELAY TO THE 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
    324764 BD PYXIS¿ ANESTHESIA STATION ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500400001500 10885403533242

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown