BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDBANK

    MDR report key: 24774136 · Received April 3, 2026

    Report

    Report Number
    2016493-2026-18828
    Event Type
    Malfunction
    Date Received
    April 3, 2026
    Date of Event
    March 6, 2026
    Report Date
    April 8, 2026
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4 AND H4: SERIAL NUMBER, UNIQUE DEVICE IDENTIFIER, AND MANUFACTURER DATE NOT AVAILABLE. 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 UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT, IT WAS DETERMINED THAT THE MEDICATION ORDER WAS NOT COMING THROUGH MEDBANK MYQLINK (MQL) TO CABINET. A TECHNICAL SUPPORT SPECIALIST FOUND THAT THE ITEM IDENTITY WAS NOT ASSIGNED, GUIDED THE CUSTOMER THROUGH MEDBANK MYQLINK (MQL) TO VERIFY THAT THE ITEM IDENTITY LISTED IN THE ORDER WAS NOT ASSIGNED TO THE CABINET. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST INVESTIGATED THE ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDBANK, THE MEDICATION ORDER WAS NOT COMING THROUGH FROM MQL TO THE PYXIS MEDBANK CABINET. THIS ISSUE WAS THE LATEST IN A SERIES OF REPEATED INCIDENTS IN WHICH NURSES HAD TO BE PROVIDED WITH ELEVATED ACCESS TO DISPENSE MEDICATIONS DUE TO ON PREMISE CABINETS NOT RECEIVING ORDER INFORMATION. AS A RESULT, PATIENT CARE WAS NEGATIVELY IMPACTED. THE CUSTOMER STATED THAT THIS MALFUNCTION OCCURRED WHILE DISPENSING THE MEDICATION AND CAUSED A DELAY TO THE PATIENT CARE. 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, THE MEDICATION ORDER WAS NOT COMING THROUGH FROM MQL TO THE PYXIS MEDBANK CABINET. THIS ISSUE WAS THE LATEST IN A SERIES OF REPEATED INCIDENTS IN WHICH NURSES HAD TO BE PROVIDED WITH ELEVATED ACCESS TO DISPENSE MEDICATIONS DUE TO ON PREMISE CABINETS NOT RECEIVING ORDER INFORMATION. AS A RESULT, PATIENT CARE WAS NEGATIVELY IMPACTED. THE CUSTOMER STATED THAT THIS MALFUNCTION OCCURRED WHILE DISPENSING THE MEDICATION AND CAUSED A DELAY TO THE PATIENT CARE. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833911 BD PYXIS¿ MEDBANK AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SN: (B)(6), LOCATION: CITRUS CR.