BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 22725903 · Received August 6, 2025

    Report

    Report Number
    2016493-2025-102913
    Event Type
    Malfunction
    Date Received
    August 6, 2025
    Date of Event
    July 9, 2025
    Report Date
    August 7, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403512667
    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 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 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, 24-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 DRAWER 1 WAS NOT OPENING. A FIELD SERVICE ENGINEER POWERED DOWN THE STATION AND DISASSEMBLED THE DRAWER PER FSG SECTION 3.11.3, REPLACED THE ROW TRAY, RESEATED THE RETRACTOR BAND AND ROW BOARD CABLES AT BOTH THE DRAWER AND MODULE CONTROLLER, REASSEMBLED THE DRAWER, POWERED ON THE DEVICE, AND VERIFIED DRAWER FUNCTIONALITY THROUGH DIAGNOSTICS. 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 WAS NOT OPENING. THE CUSTOMER STATED THERE WAS A DELAY TO THE PATIENT'S WORKFLOW. 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 WAS NOT OPENING. THE CUSTOMER STATED THERE WAS A DELAY TO THE PATIENT'S WORKFLOW. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1725180 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002500 10885403512667

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown