BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 22904044 · Received August 27, 2025

    Report

    Report Number
    2016493-2025-108522
    Event Type
    Malfunction
    Date Received
    August 27, 2025
    Date of Event
    August 2, 2025
    Report Date
    September 27, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403512667
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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, 04-SEP-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 MAIN DRAWER 2 WAS NOT ABLE TO BE RECOVERED. BARCODE SCANNER WAS ALSO INOPERABLE. THE FIELD SERVICE ENGINEER INSPECTED THE MAIN FULL-HEIGHT MATRIX DRAWER AND CONFIRMED THAT IT WAS NOT IN A FAILURE STATE. THE USER WAS UNABLE TO REPRODUCE THE REPORTED ERROR DURING THE VISIT. PHARMACY STAFF ALSO ATTEMPTED TO RECREATE THE ISSUE BUT WERE UNSUCCESSFUL. THE DRAWER REMAINED RESPONSIVE THROUGHOUT THE TESTING PROCESS. ADDITIONALLY, THE BARCODE SCANNER WAS FOUND TO BE FULLY FUNCTIONAL. IT WAS NOTED THAT THE MEDICATION STATION IS LOCATED IN AN AREA WITH VERY LOW LIGHTING. THE FSE INFORMED THE CUSTOMER THAT THE BARCODE SCANNER REQUIRES A CERTAIN LEVEL OF AMBIENT LIGHT TO OPERATE EFFECTIVELY. AFTER ADJUSTING FOR LIGHTING CONDITIONS, BOTH THE USER AND PHARMACY STAFF WERE ABLE TO USE THE BARCODE SCANNER WITHOUT ANY ISSUES. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE FIELD SERVICE ENGINEER REPAIRED THE DEVICE.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES, MAIN DRAWER 2 WAS NOT ABLE TO BE RECOVERED AND BARCODE SCANNER WAS ALSO FAILED. THE CUSTOMER STATED THAT THIS MALFUNCTION CAUSED A DELAY IN DISPENSING MEDICATION TO PATIENTS. HOWEVER, 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 WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES, MAIN DRAWER 2 WAS NOT ABLE TO BE RECOVERED AND BARCODE SCANNER WAS ALSO FAILED. THE CUSTOMER STATED THAT THIS MALFUNCTION CAUSED A DELAY IN DISPENSING MEDICATION TO PATIENTS. HOWEVER, THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1405067 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002500 10885403512667

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown