BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 24726790 · Received March 30, 2026

    Report

    Report Number
    2016493-2026-17265
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    March 5, 2026
    Report Date
    March 13, 2026
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403533228
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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, 28-FEB-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 DEVICE PREVENTIVE MAINTENANCE FAILED. A FIELD SERVICE ENGINEER GUIDED CUSTOMER TO RECOVER STORAGE SPACE OVER THE PHONE. CUSTOMER REQUESTED CASE CLOSURE. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE FIELD SERVICE ENGINEER REPAIRED THE DEVICE. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE DATA COLLECTED FOR IDENTIFICATION OF EMERGING TRENDS. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED TO BD REGARDING THE REPORTED EVENT. IF ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT RECORD WILL BE REASSESSED. MEDSTATION DOES NOT HAVE AN ALLEGATION OF THE PRODUCT. UPON FURTHER EVALUATION, THE ISSUE WAS IDENTIFIED WITH THE (SRM/RM OR Q-LOCK).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES USER WHEN ATTEMPTED TO REMOVE A REFRIGERATED MEDICATION FROM THE ADC, REFRIGERATOR LOCK DOES NOT FUNCTION CORRECTLY. THE SYSTEM INDICATED THAT THE REFRIGERATOR WAS UNLOCKED, BUT THE DOOR CANNOT BE OPENED UNLESS THE PHYSICAL KEY WAS USED. 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
    789543 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002500 10885403533228

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown GENERIC REMOTE MANAGER