BEUDAMED
    FDA Adverse Event Death Summary report: N

    BD PYXIS¿ MEDSTATION ES AUXILIARY

    MDR report key: 22247751 · Received June 17, 2025

    Report

    Report Number
    2016493-2025-87757
    Event Type
    Death
    Date Received
    June 17, 2025
    Date of Event
    May 22, 2025
    Report Date
    July 8, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403512681
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE
    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.

    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, 11-JAN-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 POWER OUTAGE AND NETWORK FAILURE PREVENTED SOME STATIONS FROM ENTERING CRITICAL OVERRIDE. AS A RESULT, USERS WERE UNABLE TO LOG IN OR ACCESS MEDICATIONS, AND THERE WAS A CODE BLUE SITUATION, AND THE STAFF WERE UNABLE TO ACCESS THE STATION OR PULL MEDS. THE CUSTOMER TRIED ANOTHER TWO STATIONS NEARBY, BUT BOTH ACTED THE SAME. THE CUSTOMER ATTEMPTED TO OBTAIN THE MEDICATION FROM THE PHARMACY, BUT UNFORTUNATELY, THE PATIENT PASSED AWAY. AFTER THE PATIENT HAD PASSED AWAY, THEY ATTEMPTED TO LOG ON AGAIN AND TIMED HOW LONG IT TOOK¿TWENTY-FOUR SECONDS TO LOG IN AND NEARLY THIRTY SECONDS TO BRING UP THE PATIENT PROFILE. A FIELD SERVICE ENGINEER ARRIVED ON SITE AND WAS INFORMED OF A PATIENT DEATH THAT OCCURRED DURING AN UNSCHEDULED DOWNTIME. VERIFIED THE SERIAL NUMBER AND NO SERVICE WAS PERFORMED ON THE STATION. THE ENGINEER REMAINED ON SITE AWAITING FURTHER INSTRUCTIONS AND DEPARTED ONLY AFTER RECEIVING AUTHORIZATION. THE WORK ORDER WAS CLOSED WITH NO REPAIRS MADE. THE CUSTOMER REPORTED THAT THE STATION WAS FULLY FUNCTIONAL, AND NO FURTHER UPDATES WERE RECEIVED FROM CUSTOMER ADVOCACY. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE ISSUE GOT RESOLVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A POWER/INTERNET OUTAGE AT THE WILLIAM BEAUMONT ARMY MEDICAL CENTER, A NURSE AND A PHARMACIST COULD NOT LOG IN TO A BD PYXIS¿ MEDSTATION ES AND OPEN A DRAWER. THIS OCCURRED DURING A CODE BLUE IN THE EMERGENCY DEPARTMENT. IT WAS REPORTED THAT THE PATIENT UNFORTUNATELY DIED. MULTIPLE ATTEMPTS HAVE BEEN MADE (6 TOTAL) TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER FOR THIS EVENT. TO DATE, BD HAS NOT RECEIVED ANY ADDITIONAL INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, THIS CASE WILL BE RE-EVALUATED. OUT OF AN ABUNDANCE OF CAUTION, THIS EVENT HAS BEEN DETERMINED TO BE REPORTABLE FOR DEATH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A POWER/INTERNET OUTAGE AT THE (B)(6), A NURSE AND A PHARMACIST COULD NOT LOG IN TO A BD PYXIS¿ MEDSTATION ES AND OPEN A DRAWER. THIS OCCURRED DURING A CODE BLUE IN THE EMERGENCY DEPARTMENT. IT WAS REPORTED THAT THE PATIENT UNFORTUNATELY DIED. MULTIPLE ATTEMPTS HAVE BEEN MADE (6 TOTAL) TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER FOR THIS EVENT. TO DATE, BD HAS NOT RECEIVED ANY ADDITIONAL INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, THIS CASE WILL BE RE-EVALUATED. OUT OF AN ABUNDANCE OF CAUTION, THIS EVENT HAS BEEN DETERMINED TO BE REPORTABLE FOR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1747173 BD PYXIS¿ MEDSTATION ES AUXILIARY AUTOMATIC DISPENSING CABINET BRY CAREFUSION 303, INC. 10885403512681

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death