BEUDAMED
    FDA Adverse Event Death Summary report: N

    PYXIS MEDSTATION ES

    MDR report key: 13042924 · Received December 20, 2021

    Report

    Report Number
    2016493-2021-00039
    Event Type
    Death
    Date Received
    December 20, 2021
    Date of Event
    November 19, 2021
    Report Date
    December 20, 2021
    Manufacturer
    CAREFUSION 303
    Product Code
    BRY
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MEDSTATION ES USER PERFORMED "VERIFY INVENTORY" FUNCTION AND CHANGED THE QUANTITY OF THE MEDICATION IN THE DRAWER FROM ONE TO ZERO AS THERE WAS NO MEDICATION IN THE DRAWER. IT WAS NOT DETERMINED HOW LONG THE MEDICATION HAD NOT BEEN IN THE DRAWER OR THE CAUSE OF THE DISCREPANCY IN THE INVENTORY COUNT. THE VERIFY INVENTORY TRANSACTION DOES NOT GENERATE A STOCKOUT TRANSACTION AT THE INTERFACE LEVEL BY DESIGN. THIS IS A TRACKED IN PRODUCTION ISSUE (B)(4). THE INVENTORY UPDATE (VERIFY INVENTORY) OCCURRED ON NOVEMBER 19, 2021 AT 22:26:41. ON (B)(6) 2021 A RESTOCK WAS PERFORMED AT 20:11:54. AT SOME POINT BETWEEN THESE TWO EVENTS A PATIENT, WHO WAS ALREADY IN CRITICAL CONDITION, EXPIRED. THE CUSTOMER STATED THAT THE DELAY IN ACCESS TO THE MEDICATION HAD AN UNDETERMINED IMPACT TO THE PATIENT OUTCOME. THIS EVENT IS CAPTURED IN COMPLAINT FILES (B)(4).

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT WHEN PERFORMING AN OUTDATE ON A PYXIS MEDSTATION ES DEVICE, AND THE VERIFIY INVENTORY STEP AND SET THE COUNT TO ZERO, A STOCKOUT NOTIFICATION WAS NOT CREATED. THE MEDICATION WAS NOT IN THE DRAWER (UNKNOWN CAUSE) AND HAD TO BE RETREIVED FROM AN ALTERNATE SOURCE. THE PATIENT WHO WAS ALREADY IN CRITICAL CONDITION EXPIRED. THE CUSTOMER STATED THAT THE DELAY IN ACCESS TO THE MEDICATION HAD AN UNDETERMINED IMPACT TO THE PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1944374 PYXIS MEDSTATION ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death