BEUDAMED
    FDA Adverse Event Death Summary report: N

    PYXIS MEDBANK TOWER

    MDR report key: 12881779 · Received November 29, 2021

    Report

    Report Number
    2016493-2021-00017
    Event Type
    Death
    Date Received
    November 29, 2021
    Date of Event
    October 29, 2021
    Report Date
    November 18, 2021
    Manufacturer
    CAREFUSION 303
    Product Code
    BRY
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ON NOVEMBER 1, 2021 BD WAS MADE AWARE THAT MEDICATION INSIDE A PYXIS MEDBANK TOWER, WAS UNABLE TO BE ACCESSED VIA OVERRIDE FOR A HYPOGLYCEMIC PATIENT. THE EVENT OCCURRED ON (B)(6) 2021 AND IS RECORDED IN COMPLAINT NUMBER (B)(4). AS A RESULT, THE USER WAS UNABLE TO ACCESS GLUCAGON THAT WAS ORDERED BY THE ATTENDING PHYSICIAN TO TREAT THE HYPOGLYCEMIA. THE PATIENTS' BLOOD SUGAR CONTINUED TO DROP AND THE PATIENT AND WAS EVENTUALLY SENT BY EMT TO THE HOSPITAL. IT WAS CONFIRMED THAT ON (B)(6) 2021 THE PATIENT EXPIRED. THE INVESTIGATION BY BD, DETERMINED THAT AN INADVERTENT SETTINGS CHANGE, WHICH CHANGED GLUCAGON FROM AN EMERGENCY MEDICATION TO NOT HAVING OVERRIDE CAPABILITY, WAS THE CAUSE OF THE INABILITY TO ACCESS. THE SOFTWARE SETTING WAS CORRECTED AND NO FURTHER INCIDENTS WERE REPORTED TO BD. IT HAS NOT BEEN CONFIRMED THAT THE INABILITY TO ACCESS GLUCAGON CAUSED OR CONTRIBUTED TO THE DEATH OF THE PATIENT.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT THEY WERE UNABLE TO ACCESS EMERGENCY MEDICATION FROM THE PYXIS MEDBANK TOWER WHILE THE PATIENT WAS HYPOGLYCEMIC. MEDICATION WAS NOT AVAILABLE VIA OVERRIDE. THE PATIENT WAS TAKEN BY EMS TO THE HOSPITAL BUT EXPIRED THE FOLLOWING DAY ((B)(6) 2021). IT HAS NOT BEEN CONFIRMED THAT THE INABILITY TO ACCESS MEDICATION CAUSED OR CONTRIBUTED TO THE DEATH OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1785294 PYXIS MEDBANK TOWER AUTOMATED DISPENSING CABINET BRY CAREFUSION 303

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female Death| H