BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD PYXIS MEDBANK TWR MN 12HH-1FH

    MDR report key: 20596591 · Received November 4, 2024

    Report

    Report Number
    2016493-2024-00759
    Event Type
    Injury
    Date Received
    November 4, 2024
    Date of Event
    October 8, 2024
    Report Date
    March 5, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403512568
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT, IT WAS DETERMINED THAT THE PATIENT ORDER WAS NOT INTEGRATING. A TECHNICAL SUPPORT SPECIALIST FOUND THAT USER HAD OVERRIDE AND ABLE TO RESOLVE. THE SYSTEM WAS FUNCTIONAL AS INTENDED.

    Additional Manufacturer Narrative · 0

    SECTION B1 - CORRECTED TO ADVERSE EVENT. SECTION B2 - UPDATED OUTCOMES ATTRIBUTED TO ADVERSE EVENT - OTHER SERIOUS OR IMPORTANT MEDICAL EVENTS. SECTION B.5 - CORRECTED DESCRIBE EVENT OR PROBLEM. SECTION H6 - UPDATED HEALTH EFFECT - CLINICAL CODE (E).

    Additional Manufacturer Narrative · 0

    CORRECTIONS AND OR ADDITIONAL INFORMATION HAS BEEN ADDED TO THE FOLLOWING SECTIONS: A1, D1, D4, D5, H6, 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 (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 PATIENT ORDER HAD NOT INTEGRATED. THE TECHNICAL SUPPORT SPECIALIST FOUND THAT THE USER HAD PERFORMED AN OVERRIDE AND WAS ABLE TO RESOLVE THE ISSUE. THE SYSTEM FUNCTIONED AS INTENDED AFTER BEING ASSESSED BY THE TECHNICAL SUPPORT SPECIALIST.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT A PYXIS MEDBANK SYSTEM DID NOT INTEGRATE PATIENT ORDER AND PREVENTED USER FROM ACCESSING THE MEDICATION GLUCAGON, CAUSING SIGNIFICANT DELAY. THE MANUFACTURER REACHED OUT TO THE CUSTOMER FOR ADDITIONAL INFORMATION REGARDING THE EVENT, BUT NO OTHER INFORMATION WAS RELEASED. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT A PYXIS MEDBANK SYSTEM DID NOT INTEGRATE PATIENT ORDER AND PREVENTED USER FROM ACCESSING THE MEDICATION GLUCAGON, CAUSING SIGNIFICANT DELAY. THE PATIENT WAS SENT TO THE HOSPITAL TO RECEIVE MEDICATION. THE MANUFACTURER REACHED OUT TO THE CUSTOMER FOR ADDITIONAL INFORMATION REGARDING THE EVENT, BUT NO OTHER INFORMATION WAS RELEASED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT A BD PYXIS MEDBANK SYSTEM DID NOT INTEGRATE PATIENT ORDER AND PREVENTED USER FROM ACCESSING THE MEDICATION GLUCAGON, CAUSING SIGNIFICANT DELAY. THE PATIENT WAS SENT TO THE HOSPITAL TO RECEIVE MEDICATION. THE MANUFACTURER REACHED OUT TO THE CUSTOMER FOR ADDITIONAL INFORMATION REGARDING THE EVENT, BUT NO OTHER INFORMATION WAS RELEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2166184 BD PYXIS MEDBANK TWR MN 12HH-1FH AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. PYXIS MEDBANK 10885403512568

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other