BEUDAMED
    FDA Adverse Event Death Summary report: N

    BD PYXIS MEDSTATION ES

    MDR report key: 14946979 · Received July 7, 2022

    Report

    Report Number
    2016493-2022-99102
    Event Type
    Death
    Date Received
    July 7, 2022
    Date of Event
    June 7, 2022
    Report Date
    March 20, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403512667
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED THAT A PYXIS MEDSTATION ES SYSTEM WOULD NOT DISPLAY A PATIENT ON THE STATION PREVENTING USER ACCESS TO MEDICATIONS. THE NATURE OF THE PROCEDURE WAS NOT DISCLOSED. THE CUSTOMER REPORTED A DELAY OF FOUR HOURS TO PATIENT CARE. CUSTOMER REPORTED PATIENT DEATH BUT DID NOT PROVIDE DETAILED INFORMATION. CUSTOMER COMMENTED THAT FURTHER DETAILS WOULD BE RELEASED ONCE HEALTH INFORMATION MANAGEMENT AND RISK MANAGEMENT DEPARTMENTS GRANT THEIR APPROVAL. THIS EVENT IS RECORDED IN COMPLAINT NUMBER (B)(4). A TECHNICAL SUPPORT SPECIALIST EVALUATED THE DEVICE'S LOG FILES AND CONFIRMED THAT THE PATIENT'S INFORMATION WAS AVAILABLE IN THE DATABASE. CUSTOMER REQUESTED A REPORT WITH THE TECHNICAL SUPPORT SPECIALIST'S FINDINGS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE CUSTOMER RELEASES ADDITIONAL INFORMATION REGARDING THE REPORTED DEATH.

    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. THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL/CORRECTED INFORMATION: A1, B5, D1, D4, D5, G1, H6, H10, H11. 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 07-JUN-2020 TO 07- JUN-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 USER HAD QUESTIONS ABOUT PATIENT NOT SHOWING UP AT THE STATION. THE TECHNICAL SUPPORT SPECIALIST REMOTED INTO THE SERVER, PULLED THE TRANSFER MESSAGE AND SENT IT TO THE CUSTOMER TO RESOLVE THE ISSUE. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST ASSESSED THE DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT A PYXIS MEDSTATION ES SYSTEM WOULD NOT DISPLAY A PATIENT ON THE STATION PREVENTING USER ACCESS TO MEDICATIONS. THE NATURE OF THE PROCEDURE WAS NOT DISCLOSED. THE CUSTOMER REPORTED A DELAY OF FOUR HOURS TO PATIENT CARE. CUSTOMER REPORTED PATIENT DEATH BUT DID NOT PROVIDE DETAILED INFORMATION. CUSTOMER COMMENTED THAT FURTHER DETAILS WOULD BE RELEASED ONCE HEALTH INFORMATION MANAGEMENT AND RISK MANAGEMENT DEPARTMENTS GRANT THEIR APPROVAL.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT A PYXIS MEDSTATION ES SYSTEM WOULD NOT DISPLAY A PATIENT ON THE STATION PREVENTING USER ACCESS TO MEDICATIONS. THE MEDS REQUIRED AT THE TIME WERE IV MEDS IN THE PYXIS. THE NATURE OF THE PROCEDURE WAS NOT DISCLOSED. THE CUSTOMER REPORTED A DELAY OF FOUR HOURS TO PATIENT CARE. CUSTOMER REPORTED PATIENT DEATH BUT DID NOT PROVIDE DETAILED INFORMATION. CUSTOMER COMMENTED THAT FURTHER DETAILS WOULD BE RELEASED ONCE HEALTH INFORMATION MANAGEMENT AND RISK MANAGEMENT DEPARTMENTS GRANT THEIR APPROVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1256690 BD PYXIS MEDSTATION ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 323 10885403512667

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death