BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDBANK TOWER

    MDR report key: 24762526 · Received April 2, 2026

    Report

    Report Number
    2016493-2026-18449
    Event Type
    Malfunction
    Date Received
    April 2, 2026
    Date of Event
    March 10, 2026
    Report Date
    March 25, 2026
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403512568
    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, 26-AUG-2020 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 HAD AN ISSUE WHERE MEDICATION WAS ISSUED WITHOUT VALIDATION CODE. A TECHNICAL SUPPORT SPECIALIST (TSS) SHARED THE TRANSACTION DETAILS AND EXPLAINED WHY A VALIDATION CODE WAS NOT RECORDED FOR THE LORAZEPAM TRANSACTION. THE TSS STATED THAT THE ISSUE WAS RELATED TO PRODUCTION ISSUE 54156, IN WHICH A TIMEOUT ON THE ISSUE SCREEN OF A KEY ITEM RESULTED IN A BLIND ISSUE OF EXT LORAZEPAM WITHOUT REQUIRING A VALIDATION CODE OR A COUNTBACK. IT WAS ALSO ASSOCIATED WITH BUG 54464, WHERE A TIMEOUT ON THE ACCESSPIN (VALIDATION CODE PROMPT) SCREEN FOR A KEY-COMBO ITEM CAUSED THE WORKFLOW TO MOVE TO THE NEXT SCREEN. THE TSS EXPLAINED THAT WHEN THE PHARMACY PROVIDED VALIDATION CODE SETTING WAS ENABLED BUT THE USER TIMED OUT ON THE ACCESSPIN SCREEN, THE SYSTEM PROCEEDED TO THE NEXT APPROPRIATE STEP IN THE KEY-COMBO WORKFLOW FOR EXAMPLE, ADVANCING TO THE WITNESS SCREEN IF A WITNESS WAS REQUIRED, OR DIRECTLY TO THE KEY-ISSUE SCREEN IF NO WITNESS WAS NEEDED. THE TRANSACTION LOGS FROM THE CABINET SHOWED THAT THE USER LOGGED IN AT 21:57, PROGRESSED TO THE ISSUE WORKFLOW, AND THEN THE WORKFLOW REMAINED IDLE UNTIL 22:58, WHEN THE USER RETURNED AND EXITED. NO ADDITIONAL WORKFLOW ACTIVITY OCCURRED DURING THAT TIME. THE ACCESSPIN PAGE REPRESENTED THE VALIDATION CODE PROMPT. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST ASSESSED THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDBANK TOWER A MEDICATION WAS DISPENSED ON (B)(6) 2026 AT 9:31 PM WITHOUT REQUIRED A VALIDATION CODE. THE MEDICATION WAS PART OF A KEY-CONTROLLED COMBINATION, YET THE KEY WAS NOT REQUESTED FOR RETURN. THE CUSTOMER ASKED HOW THIS COULD HAVE OCCURRED, NOTING THAT TRANSACTION RECORDS APPEAR NORMAL AND NO ISSUES WERE IDENTIFIED ON THE CABINET OR ITEM SETTINGS. DESPITE THIS, THE NURSE WAS ABLE TO DISPENSE THE MEDICATION WITHOUT A VALIDATION CODE. THE CUSTOMER STATED THAT THIS MALFUNCTION OCCURRED WHILE DISPENSING THE MEDICATION. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    827206 BD PYXIS¿ MEDBANK TOWER AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500004500000 10885403512568

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown