BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDBANK TOWER

    MDR report key: 22309246 · Received June 23, 2025

    Report

    Report Number
    2016493-2025-89405
    Event Type
    Malfunction
    Date Received
    June 23, 2025
    Date of Event
    May 28, 2025
    Report Date
    June 20, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403512568
    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 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, 13-JUL-2023 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 SYSTEM DISPLAYED A QOH (QUANTITY ON HAND) OF 0.00 DUE TO THE INABILITY TO PERFORM A CYCLE COUNT. A TECHNICAL SUPPORT SPECIALIST ADVISED THE CUSTOMER TO CONTACT THE PHARMACY DIRECTLY FOR EMERGENCY MEDICATION ISSUANCE, AS THE SYSTEM COULD NOT OVERRIDE THE QOH WITHOUT A COMPLETED CYCLE COUNT. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST VERIFIED THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT WHEN USING THE BD PYXIS¿ MEDBANK TOWER, THE SYSTEM UNABLE TO DISPENSE MEDICATION (MORPHINE SUL SOL 100/5ML). THE CUSTOMER STATED THAT THIS MALFUNCTION OCCURRED WHILE DISPENSING MEDICATION TO PATIENT. HOWEVER, THERE WERE NO DELAY OR ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838121 BD PYXIS¿ MEDBANK TOWER AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 169-25 10885403512568

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown