BEUDAMED
    FDA Adverse Event Death Summary report: N

    BD PYXIS¿ MEDBANK TOWER

    MDR report key: 21807995 · Received April 9, 2025

    Report

    Report Number
    2016493-2025-72076
    Event Type
    Death
    Date Received
    April 9, 2025
    Date of Event
    March 13, 2025
    Report Date
    June 4, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT HISTORY REVIEW: 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. DEVICE HISTORY REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD FOR SN (B)(6) WAS PERFORMED FROM THE DATE OF MANUFACTURE, 30-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. INVESTIGATION SUMMARY: UPON INVESTIGATING THE DEVICE INVOLVED IN THIS INCIDENT, IT WAS DETERMINED THAT THE USER DID NOT CLICK THE ADD ITEMS BUTTON TO ADD NARCAN TO THE PATIENT PROFILE, WHICH CAUSED THE MEDICATION TO BE UNAVAILABLE FOR DISPENSING AT THAT TIME. A TECHNICAL SUPPORT SPECIALIST ASSISTED THE USER IN CLICKING THE ADD ITEMS BUTTON ADDING NARCAN TO THE PATIENT PROFILE WITH GENERAL OVERRIDE PERMISSIONS, THE USER HAD ACCESS TO THE MEDICATION THROUGH THE ADD ITEMS FEATURE. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST TROUBLESHOT THE DEVICE.

    Additional Manufacturer Narrative · 0

    COMPLAINT HISTORY REVIEW: 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. DEVICE HISTORY REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD FOR SN (B)(6) WAS PERFORMED FROM THE DATE OF MANUFACTURE, 30-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. INVESTIGATION SUMMARY: UPON INVESTIGATING THE DEVICE INVOLVED IN THIS INCIDENT BY REVIEWING LOG FILES, IT WAS DETERMINED THAT USER WAS NOT ABLE TO ACCESS THE NARCAN MEDICATION, WHICH WAS AVAILABLE FOR DISPENSING IN THE DEVICE, BECAUSE THE USER DID NOT ADD THIS DRUG TO THE PATIENT PROFILE. THIS IS DONE BY CLICKING THE ADD ITEMS BUTTON ONTO THE PROFILE. TSC CONFIRMED THE USER HAD GENERAL ACCESS, AND THE ITEM WAS GENERAL OVERRIDE. THIS INCIDENT IS DUE TO USE ERROR. IT IS NOT A MALFUNCTION OF THE DEVICE. THE DEVICE FUNCTIONED AS INTENDED DURING THE INCIDENT.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD PYXIS¿ MEDBANK TOWER THE USER LOGGED IN TO OBTAIN NARCAN DURING AN "EMERGENCY SITUATION" IN A REHABILITATION FACILITY. HOWEVER, THE MEDICATION REPORTEDLY DID NOT SHOW UNDER THE PATIENT PROFILE. THE DELAY REPORTEDLY RESULTED IN "NOT BEING ABLE TO SAVE THE RESIDENT." THE CUSTOMER REPORTED THAT THE DEVICE DID HAVE 2 NARCAN VIALS. PRELIMINARY INVESTIGATION REVEALED THAT THE ISSUE WAS DUE TO USE ERROR. IT WAS REPORTED THAT SINCE THE MEDICATION WAS NOT ON THE PATIENT PROFILE, THE USER NEEDED TO CLICK THE ADD ITEM BUTTON TO ADD NARCAN ONTO THE PATIENT PROFILE. THE DEVICE KEYSTROKE LOGS SHOW THAT USER DID NOT CLICK THE ADD ITEM BUTTON AT THE TIME OF THE EVENT. IT WAS CONFIRMED THAT THE USER HAS DEVICE PERMISSION FOR GENERAL OVERRIDE, WHICH WOULD ALLOW THEM TO USE THE ADD ITEM OVERRIDE FEATURE AND ACCESS THE MEDICATION. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION, NO RESPONSE HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD PYXIS¿ MEDBANK TOWER THE USER LOGGED IN TO OBTAIN NARCAN DURING AN "EMERGENCY SITUATION" IN A REHABILITATION FACILITY. HOWEVER, THE MEDICATION REPORTEDLY DID NOT SHOW UNDER THE PATIENT PROFILE. THE DELAY REPORTEDLY RESULTED IN "NOT BEING ABLE TO SAVE THE RESIDENT." THE CUSTOMER REPORTED THAT THE DEVICE DID HAVE 2 NARCAN VIALS. PRELIMINARY INVESTIGATION REVEALED THAT THE ISSUE WAS DUE TO USE ERROR. IT WAS REPORTED THAT SINCE THE MEDICATION WAS NOT ON THE PATIENT PROFILE, THE USER NEEDED TO CLICK THE ADD ITEM BUTTON TO ADD NARCAN ONTO THE PATIENT PROFILE. THE DEVICE KEYSTROKE LOGS SHOW THAT USER DID NOT CLICK THE ADD ITEM BUTTON AT THE TIME OF THE EVENT. IT WAS CONFIRMED THAT THE USER HAS DEVICE PERMISSION FOR GENERAL OVERRIDE, WHICH WOULD ALLOW THEM TO USE THE ADD ITEM OVERRIDE FEATURE AND ACCESS THE MEDICATION. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION, NO RESPONSE HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1816138 BD PYXIS¿ MEDBANK TOWER AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death