BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 22078810 · Received May 23, 2025

    Report

    Report Number
    2016493-2025-82675
    Event Type
    Malfunction
    Date Received
    May 23, 2025
    Date of Event
    April 28, 2025
    Report Date
    May 22, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403512667
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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, 19-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 DEVICE INVOLVED IN THIS INCIDENT, IT WAS DETERMINED THAT THE SMART REMOTE MANAGER WAS READING A TEMPERATURE OF 8 DEGREES. A FIELD SERVICE ENGINEER (FSE) REBOOTED THE STATION AND CALIBRATED THE TEMPERATURE PROBE. THE FSE VERIFIED THE FUNCTIONALITY OF THE DEVICE USING THE HARDWARE TESTING APPLICATION (HTA). THE FSE PERFORMED TEMPERATURE CALIBRATION VERIFICATION IN ACCORDANCE WITH THE PYXIS SMART REMOTE MANAGER VALIDATION AND CALIBRATION GUIDE AND PROVIDED REOTEMP (EQN:102762). THE SMART REMOTE MANAGER DISPLAYED A TEMPERATURE OF 45°F, WHILE THE REOTEMP DISPLAYED 45.3°F. THE TEMPERATURE PROBE WAS CONFIRMED TO BE FUNCTIONAL AND WITHIN THE TOLERANCE SPECIFIED 2°F OR ±1.1°C. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE FIELD SERVICE ENGINEER TROUBLESHOT THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES, THE SMART REMOTE MANAGER WAS READING A TEMPERATURE OF 8¿9°F. THE CUSTOMER STATED THAT THIS MALFUNCTION CAUSED A DELAY IN DISPENSING THE MEDICATIONS TO THE PATIENT. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2514295 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 323 10885403512667

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown