BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ ES SERVER

    MDR report key: 22644004 · Received July 29, 2025

    Report

    Report Number
    2016493-2025-101069
    Event Type
    Malfunction
    Date Received
    July 29, 2025
    Date of Event
    July 8, 2025
    Report Date
    August 13, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHARMACIST
    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. D4 & H4: SERIAL NUMBER, UNIQUE DEVICE IDENTIFIER AND MANUFACTURER DATE NOT AVAILABLE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION H IMDRF ANNEX CODES. CORRECTION: SECTION D CONCOMITANT MED PROD DATA SN'S (B)(6) ADDED. UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT, IT WAS DETERMINED THAT THE FOUND MESSAGE FAILED TO PROCESS DUE TO 'PRIORVISITNUMBER' WITHIN THE 'PATIENTMERGEINFO' WAS NOT POPULATED. A TECHNICAL SUPPORT SPECIALIST INSTRUCTED THE CUSTOMER THAT MRG.3 WAS THE ONLY POPULATED ITEM IN THE MRG SEGMENT, A42 REQUIRES MRG.1 AND MRG.5 FOR THE TAGS 'PRIORVISITNUMBER' AND 'PATIENTMERGEINFO' TO POPULATE IN CMS MESSAGE TO ES AND CUSTOMER AGREED AND ADJUSTED LOGIC ON HOST SIDE TO RESOLVE THE ISSUE. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST TROUBLESHOT THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT A BD PYXIS¿ ES SERVER BD PYXIS SYSTEM NOT PROCESSING MESSAGES CORRECTLY. THE CUSTOMER STATED THAT THIS MALFUNCTION CAUSED A DELAY IN DISPENSING MEDICATION TO PATIENTS. 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¿ ES SERVER BD PYXIS SYSTEM NOT PROCESSING MESSAGES CORRECTLY. THE CUSTOMER STATED THAT THIS MALFUNCTION CAUSED A DELAY IN DISPENSING MEDICATION TO PATIENTS. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1062239 BD PYXIS¿ ES SERVER AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown S/N: (B)(6), LOCATION: PHARMACY.