BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES AUXILIARY

    MDR report key: 21960350 · Received May 5, 2025

    Report

    Report Number
    2016493-2025-78075
    Event Type
    Malfunction
    Date Received
    May 5, 2025
    Date of Event
    April 8, 2025
    Report Date
    May 5, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403512681
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 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, 13-JUL-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. UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT, IT WAS DETERMINED THAT THE NATIONAL TIME PROTOCOL (NTP) SERVER HAD FAILED DUE TO DAYLIGHT SAVING BEING CHECKED. A TECHNICAL SUPPORT SPECIALIST UNCHECKED THE DAYLIGHT SAVING IN THE STATION TEMPORARILY TO RESOLVE. THE HEALTH INFORMATION TECHNOLOGY (HIT) TEAM THEN UPDATED THE NEW NATIONAL TIME PROTOCOL. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST AND HIT TEAM TROUBLESHOT THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES AUXILIARY, THE TIME WAS OFF BY ONE HOUR. THE CUSTOMER REPORTED THAT THE MALFUNCTION RESULTED DELAY IN DISPENSING OF THE MEDICATION TO THE PATIENT. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458362 BD PYXIS¿ MEDSTATION¿ ES AUXILIARY AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 324 10885403512681

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown