BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD PYXIS MEDSTATION ES

    MDR report key: 19890525 · Received August 2, 2024

    Report

    Report Number
    2016493-2024-00478
    Event Type
    Injury
    Date Received
    August 2, 2024
    Date of Event
    July 10, 2024
    Report Date
    March 7, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REGULATORY REPORT IS BEING SUBMITTED DUE TO A RETROSPECTIVE REVIEW CONDUCTED THROUGH CAPA 10308384. THE LATE SUBMISSION OF THIS SUPPLEMENTAL REPORT IS DUE TO THE THOROUGH AND DETAILED NATURE OF THE RETROSPECTIVE REVIEW PROCESS. THIS PROCESS WAS ESSENTIAL TO ACCURATELY CAPTURE ALL RELEVANT DATA AND ENSURE THE INTEGRITY OF OUR REPORTING. WE HAVE INCLUDED THE CAPA REFERENCE FOR THE RETROSPECTIVE REVIEW IN THE ADDITIONAL MANUFACTURER NARRATIVE SECTION OF THE FDA FORM 3500A, AS RECOMMENDED. 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 (B)(6)2022 TO (B)(6)2024 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 DEVICE EXPERIENCED FAILED HARDWARE DURING NURSES WERE PULLING GLUCOSE. A FIELD SERVICE ENGINEER RECOVERED STORAGE SPACE ON DRAWER 3. CHECKED BACK DRAWER 4 AND HYDROCORTISONE BOXES FOR ANY OBSTRUCTIONS. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE FIELD SERVICE ENGINEER TROUBLESHOT THE DEVICE.

    Additional Manufacturer Narrative · 0

    UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT IT WAS DETERMINED THAT FAILED STORAGE SPACE ON DRAWER 3. A FIELD SERVICE ENGINEER WORKED WITH CUSTOMER TO RECOVER THE STORAGE SPACE AND SUSPECTED THAT HYDROCORTISONE BOXES ON DRAWER 4 COULD HAVE POSSIBLY CAUSED AN OBSTRUCTION. THE SYSTEM WAS FUNCTIONAL AS INTENDED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT A PYXIS MEDSTATION ES SYSTEM FAILED HARDWARE EVENT PREVENTED NURSES FROM REMOVING THE INSTANT GLUCOSE WHEN A PATIENT WAS EXPERIENCING HYPOGLYCEMIA. CUSTOMER STATED THAT STAFF MEMBERS WERE FORCED TO FIND ALTERNATIVE MEANS TO BRING THE PATIENT'S GLUCOSE LEVELS BACK INTO RANGE, BUT IT WAS UNSUCCESSFUL, SO THE PATIENT REQUIRED TO BE TRANSFERRED TO EMERGENCY DEPARTMENT. THE CUSTOMER WAS UNAWARE ABOUT PATIENT'S OUTCOME ATTRIBUTED TO THE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT A PYXIS MEDSTATION ES SYSTEM FAILED HARDWARE EVENT PREVENTED NURSES FROM REMOVING THE INSTANT GLUCOSE WHEN A PATIENT WAS EXPERIENCING HYPOGLYCEMIA. CUSTOMER STATED THAT STAFF MEMBERS WERE FORCED TO FIND ALTERNATIVE MEANS TO BRING THE PATIENT'S GLUCOSE LEVELS BACK INTO RANGE, BUT IT WAS UNSUCCESSFUL, SO THE PATIENT REQUIRED TO BE TRANSFERRED TO EMERGENCY DEPARTMENT. THE CUSTOMER WAS UNAWARE ABOUT PATIENT'S OUTCOME ATTRIBUTED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    984908 BD PYXIS MEDSTATION ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 323

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other