BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDBANK TOWER

    MDR report key: 22046999 · Received May 19, 2025

    Report

    Report Number
    2016493-2025-81249
    Event Type
    Malfunction
    Date Received
    May 19, 2025
    Date of Event
    April 22, 2025
    Report Date
    May 16, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403512568
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 COMPLAINTS 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, 15-JUN-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 DEVICE INVOLVED IN THE INCIDENT, IT WAS DETERMINED THAT THE CUBIE LID WAS NOT OPENED TO ISSUE MEDICATION. A TECHNICAL SUPPORT SPECIALIST CONFIRMED THE CUSTOMER CYCLE COUNTED THE ITEM OR BIN TO TAKE 1 TABLET OUT AND THEN ADJUST THE QUANTITY ON HAND (QOH) AND GENERATED A DISCREPANCY. THE CUSTOMER DOCUMENTED THE PREVIOUS DISCREPANCY CREATED BY ANOTHER EMPLOYEE AND THE ONE THEY CREATED DURING THE CYCLE COUNT. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE CUSTOMER RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDBANK TOWER, THE CUBIE LID WAS NOT OPENED TO ISSUE MEDICATION. THE CUSTOMER REPORTED THAT A MALFUNCTION TOOK PLACE WHEN THE USER TRIED TO DISPENSE MEDICATION TO THE PATIENT. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166421 BD PYXIS¿ MEDBANK TOWER AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 169-132 10885403512568

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown