BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDBANK TOWER

    MDR report key: 22591896 · Received July 24, 2025

    Report

    Report Number
    2016493-2025-99977
    Event Type
    Malfunction
    Date Received
    July 24, 2025
    Date of Event
    July 2, 2025
    Report Date
    August 7, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403517167
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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, 20-MAR-2025 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 UNABLE TO ISSUE MEDICATION. A TECHNICAL SUPPORT SPECIALIST REMOTELY ACCESSED THE CABINET TO PERFORM TROUBLESHOOTING AND FOUND THAT THE ISSUE REQUIRED A SERVICE RESTART. THE TSS RESTARTED THE ASP SYNC SERVICE, WHICH SUCCESSFULLY RESOLVED THE PROBLEM. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST TROUBLESHOT THE DEVICE.

    Additional Manufacturer Narrative · 0

    CORRECTION: SECTION H USAGE OF DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT WHEN USING THEBD PYXIS¿ MEDBANK TOWER, UNABLE TO ISSUE HYDROMORPHONE 2MD TABLET CII. THE CUSTOMER STATED THAT THERE WAS NO DELAY, BUT THE MALFUNCTION OCCURRED WHEN THE USER TRIED TO ISSUE MEDICATION TO THE PATIENT. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED DUE TO THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT WHEN USING THE BD PYXIS¿ MEDBANK TOWER, UNABLE TO ISSUE HYDROMORPHONE 2MD TABLET CII. THE CUSTOMER STATED THAT THERE WAS NO DELAY, BUT THE MALFUNCTION OCCURRED WHEN THE USER TRIED TO ISSUE MEDICATION TO THE PATIENT. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1921820 BD PYXIS¿ MEDBANK TOWER AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500004500000 10885403517167

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown