BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDBANK MINI

    MDR report key: 25252691 · Received May 22, 2026

    Report

    Report Number
    2016493-2026-31125
    Event Type
    Malfunction
    Date Received
    May 22, 2026
    Date of Event
    April 27, 2026
    Report Date
    April 29, 2026
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403512544
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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, 31-OCT-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 THE CR STOPPED SYNCING AND REQUIRED MANUAL SUPPORT INTERVENTION TO RESTART THE SYNCHRONIZATION PROCESS, AN ISSUE THAT HAS REPORTEDLY OCCURRED AFTER EVERY MQL MAINTENANCE AND HAS LED TO DELAYED PURCHASE ORDERS AND MEDPASS WORKFLOWS. A TECHNICAL SUPPORT SPECIALIST (TSS) CONFIRMED THAT THE ISSUE WAS RELATED TO PRODUCT INCIDENT (PI) 56595 AND PI 61519, WHICH TRACK ASP SYNC CONNECTIVITY ISSUES RELATED TO WEB SERVER ERRORS. AFTER REVIEWING UPDATES FROM THE MEDBANK SUPPORT TEAM, IT WAS CONFIRMED THAT THIS INTERRUPTION WAS A KNOWN RECURRING BEHAVIOR FOR SOM SITES DURING MQL MAINTENANCE. THE TSS REMOTED IN AND CHANGED TO WS URL FROM WS2 URL AND ALL MEDPASS AND CR SYSTEMS STARTED SYNCING. THEN THE TSS CONFIRMED TO PROACTIVELY MONITOR THE RELATED PI AND ENSURE TIMELY ACTIONS ARE TAKEN IN THE FUTURE TO PREVENT OR QUICKLY RESOLVE SIMILAR POST-MAINTENANCE SYNC DISRUPTIONS. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST TROUBLESHOT THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDBANK MINI FOLLOWED THE MONTHLY MYQLINK (MQL) MAINTENANCE EVENT EXPERIENCED CR SYNCHRONIZATION FAILURE AT CFP. AFTER THE MOST RECENT MAINTENANCE, THE CR STOPPED SYNCING AND REQUIRED SUPPORT INTERVENTION TO RESTART THE SYNCHRONIZATION PROCESS. THIS ISSUE HAD BEEN OCCURRING CONSISTENTLY AFTER EACH MQL MAINTENANCE EVENT, LEADED TO INCREASED FRUSTRATION AMONG CFP LEADERSHIP. THE RECURRING FAILURE WAS IMPACTING PURCHASE ORDERS (POS) AND CAUSED DELAYS ON MEDICATION ADMINISTRATION (MEDPASS). THE CUSTOMER STATED THAT THERE WAS A DELAY IN 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
    190467 BD PYXIS¿ MEDBANK MINI AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500004500500 10885403512544

    Patients

    Seq Age Sex Outcome Treatment
    1