BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDBANK TOWER AUX

    MDR report key: 22833410 · Received August 18, 2025

    Report

    Report Number
    2016493-2025-106293
    Event Type
    Malfunction
    Date Received
    August 18, 2025
    Date of Event
    July 25, 2025
    Report Date
    August 23, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. D4 & H4: SERIAL NUMBER, UNIQUE DEVICE IDENTIFIER AND MANUFACTURER DATE NOT AVAILABLE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION H IMDRF ANNEX CODES. UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT, IT WAS DETERMINED THAT THE USER WAS UNABLE TO ISSUE ITEM TO PATIENT. A TECHNICAL SUPPORT SPECIALIST ADVISED CUSTOMER TO CONTACT THE PHARMACY TO UPDATE THE QUALITY ON HAND (QOH) OF THE ITEM.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT A BD PYXIS¿ MEDBANK TOWER AUX, THE USER WAS UNABLE TO ISSUE MEDICATION TO A PATIENT. THE CUSTOMER STATED THAT THE MALFUNCTION OCCURRED WHILE USER TRIED TO ISSUE MEDICATION TO A PATIENT. 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 BD PYXIS¿ MEDBANK TOWER AUX, THE USER WAS UNABLE TO ISSUE MEDICATION TO A PATIENT. THE CUSTOMER STATED THAT THE MALFUNCTION OCCURRED WHILE USER TRIED TO ISSUE MEDICATION TO A PATIENT. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1961220 BD PYXIS¿ MEDBANK TOWER AUX AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500004500001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown