BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDBANK TOWER

    MDR report key: 23227323 · Received October 6, 2025

    Report

    Report Number
    2016493-2025-119842
    Event Type
    Malfunction
    Date Received
    October 6, 2025
    Date of Event
    September 8, 2025
    Report Date
    October 7, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403512568
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION H IMDRF ANNEX CODES. A REVIEW OF THE COMPLAINT HISTORY FOR SN (B)(6) WAS PERFORMED IN SALESFORCE WHICH DID NOT LOCATE SIMILAR COMPLAINT(S) WITH THE SAME FAILURE MODE FOR THIS SERIAL NUMBER. A REVIEW OF THE DEVICE HISTORY RECORD FOR SN (B)(6) WAS PERFORMED FROM THE DATE OF MANUFACTURE, 10-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 ORDER WAS NOT ACTIVE IN MEDBANK MYQLINK (MQL). A TECHNICAL SUPPORT SPECIALIST FOUND ORDER ID (B)(4) WAS CORRECTLY CLOSED IN MQL AS THE TOTAL QUANTITY (60) MATCHED THE TOTAL PHARMACY FILLED (60) OUTSIDE THE MEDBANK SYSTEM, FULFILLING THE ORDER PER DEFINED LOGIC. INVESTIGATION REVEALED THAT A RECENT HSCE UPDATE ENABLED THE RXE-10 FIELD TO PUSH THROUGH TO MYQLINK, WHICH IS NOT ALIGNED WITH FACILITY EXPECTATIONS. IT WAS RECOMMENDED TO IMPLEMENT A PROCEDURE TO PREVENT RXE-10 DATA FROM BEING PASSED FORWARD. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST INVESTIGATED THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDBANK TOWER USER INFORMED ORDER ACTIVE IN QS1 BUT SHOWING AS CLOSED IN MQL AND THEY HAVE PUT OVERRIDE TO ISSUE THE ITEM. THE CUSTOMER REPORTED THAT A MALFUNCTION OCCURRED WHILE THE USER WAS ATTEMPTING TO DISPENSE MEDICATION TO THE PATIENT. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDBANK TOWER USER INFORMED ORDER ACTIVE IN QS1 BUT SHOWING AS CLOSED IN MQL AND THEY HAVE PUT OVERRIDE TO ISSUE THE ITEM. THE CUSTOMER REPORTED THAT A MALFUNCTION OCCURRED WHILE THE USER WAS ATTEMPTING TO DISPENSE MEDICATION TO THE PATIENT. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2342826 BD PYXIS¿ MEDBANK TOWER AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500004500000 10885403512568

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown