BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDBANK TOWER

    MDR report key: 23037642 · Received September 12, 2025

    Report

    Report Number
    2016493-2025-113559
    Event Type
    Malfunction
    Date Received
    September 12, 2025
    Date of Event
    August 18, 2025
    Report Date
    October 15, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403517167
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION H IMDRF ANNEX CODES. 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, 03-DEC-2024 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 CUBIE REPEATEDLY POPPED OPEN DURING USE. A FIELD SERVICE ENGINEER IDENTIFIED A DAMAGED SPRING CLIP RESPONSIBLE FOR RETAINING THE POCKET IN PLACE. TO RESOLVE THE ISSUE, THE ENTIRE ROW BOARD WAS REPLACED WITH A NEW ONE. POST-REPLACEMENT, THE UNIT WAS TESTED USING THE BUILT-IN MEDBANK TEST HARDWARE APPLICATION AND VERIFIED TO BE FULLY FUNCTIONAL. ADDITIONAL STEPS INCLUDED: INSPECTING AND POPPING ALL POCKETS IN THE REMAINING TWO ROWS TO ENSURE NO OBSTRUCTIONS OR ITEMS WERE LODGED UNDERNEATH. VERIFYING ALL BOARD CONNECTIONS WERE SECURE. DISCOVERING A SPILL IN DRAWERS THREE AND FOUR AT THE FRONT. FSE REMOVED THE QBS AND ROW BOARDS, THOROUGHLY CLEANED THE TRAY INTERIOR WITH ALCOHOL AND A MICROFIBER RAG, AND WIPED DOWN THE FRONT OF THE ROW BOARDS WITH ALCOHOL WIPES. CONFIRMING THAT THE FRONT ROW BOARDS AND CUBES WERE CLEAN AND OPERATIONAL, LIKELY DUE TO RECENT REPLACEMENT DURING DEVICE REFILLING. CONDUCTING A GENERAL CLEANING AND INSPECTION OF THE UNIT, CONFIRMING ALL CABLES WERE PROPERLY WRAPPED AND UNDAMAGED. THE REMOVED ROW BOARD WILL BE RETURNED. THE UNIT IS NOW CLEAN, INSPECTED, AND FUNCTIONING AS EXPECTED. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE FIELD SERVICE ENGINEER REPAIRED THE DEVICE.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDBANK TOWER, CUBIE REPEATEDLY POPPED OPEN DURING USE. THE CUSTOMER STATED THAT THE MALFUNCTION OCCURRED WHILE A USER WAS PERFORMING A RESTOCK. AFTER SCANNING THE BARCODE AND RETRIEVING THE CUBIE TO REPLACE MEDICATIONS, THE SYSTEM DID NOT ALLOW THE CUBIE TO BE RETURNED TO THE CABINET. THE USER TRIED USING THE OLD CUBIE TO START OVER, BUT IT WOULD NOT ACCEPT IT. HOWEVER, THERE WERE NO DELAY OR ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT WHEN USING THE BD PYXIS¿ MEDBANK TOWER, CUBIE REPEATEDLY POPPED OPEN DURING USE. THE CUSTOMER STATED THAT THE MALFUNCTION OCCURRED WHILE A USER WAS PERFORMING A RESTOCK. AFTER SCANNING THE BARCODE AND RETRIEVING THE CUBIE TO REPLACE MEDICATIONS, THE SYSTEM DID NOT ALLOW THE CUBIE TO BE RETURNED TO THE CABINET. THE USER TRIED USING THE OLD CUBIE TO START OVER, BUT IT WOULD NOT ACCEPT IT. 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
    2305568 BD PYXIS¿ MEDBANK TOWER AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500004500000 10885403517167

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown