BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 23670551 · Received November 28, 2025

    Report

    Report Number
    2016493-2025-138991
    Event Type
    Malfunction
    Date Received
    November 28, 2025
    Date of Event
    November 4, 2025
    Report Date
    December 8, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403533228
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL MDR WAS FILED TO CORRECT THE MEDICAL DEVICE LOT, UNIQUE IDENTIFIER (UDI) , INITIAL REPORTER FIRST NAME, LAT NAME, DEVICE MANUFACTURE DATE, MANUFACTURER NARRATIVE. A REVIEW OF THE DEVICE HISTORY RECORD FOR SN (B)(6) WAS PERFORMED FROM THE DATE OF MANUFACTURE, 29-NOV-2022 AND CONFIRMED THAT THIS DEVICE WAS NOT PREVIOUSLY RETURNED FOR SERVICING AND THERE WERE NO PRODUCTION FAILURES WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE.

    Additional Manufacturer Narrative · 0

    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, 27-DEC-2018 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 LIST OF PATIENTS INFORMATION WAS NOT SHOWN ON THE STATION. THE TECHNICAL SUPPORT SPECIALIST (TSS) DIALED INTO DEVICE AND IDENTIFIED THAT MANUAL RECOVERY WAS REQUIRED DUE TO AN ERROR WHERE THE LAST UPLOAD CHANGE TRACKING VALUE 3203420 WAS LESS THAN THE MINIMUM VALID VERSION 3203431 IN THE STATION DATA BASE. THE RECOVERY PROCESS WAS PERFORMED FOLLOWING KNOWLEDGE ARTICLE "MANUAL RECOVERY REQUIRED: DATASYNCINVALIDUPLOADCHANGETRACKINGVALUE". AFTER RECOVERY, CUSTOMER MONITORING CONFIRMED SUCCESSFUL UPLOADS AND STABLE CHANGE TRACKING VERSIONS, WITH NO FURTHER VARIATIONS OBSERVED. THE CASE WAS CLOSED. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST TROUBLESHOOT THE ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES, LIST OF PATIENTS INFORMATION WAS NOT SHOWN ON THE STATION. 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 THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES, LIST OF PATIENTS INFORMATION WAS NOT SHOWN ON THE STATION. 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
    2443728 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002500 (01)10885403533228(21)16173476 10885403533228

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown