BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 23150923 · Received September 25, 2025

    Report

    Report Number
    2016493-2025-117859
    Event Type
    Malfunction
    Date Received
    September 25, 2025
    Date of Event
    September 1, 2025
    Report Date
    September 26, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403512667
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION H IMDRF ANNEX CODES. A REVIEW OF THE COMPLAINT HISTORY FOR SN (B)(6) WAS PERFORMED IN SALESFORCE WHICH DID NOT LOCATE SIMILAR COMPLAINTS 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, 15-NOV-2019 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 DRAWER 5 WAS FAILED TO OPEN. A FIELD SERVICE ENGINEER REPLACED INSEPARABLE AND REMOVED DEBRIS AND TESTED. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE FIELD SERVICE ENGINEER REPAIRED THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT A BD PYXIS¿ MEDSTATION¿ ES DRAWER FAILED TO OPEN. THE CUSTOMER STATED THAT MALFUNCTION CAUSED DELAY WHEN USER WAS TRYING TO ISSUE MEDICATION TO PATIENT AND USER MANAGED TO GET MEDICATIONS FROM OTHER RESOURCE. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT A BD PYXIS¿ MEDSTATION¿ ES DRAWER FAILED TO OPEN. THE CUSTOMER STATED THAT MALFUNCTION CAUSED DELAY WHEN USER WAS TRYING TO ISSUE MEDICATION TO PATIENT AND USER MANAGED TO GET MEDICATIONS FROM OTHER RESOURCE. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2861602 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002500 10885403512667

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown