BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 22331795 · Received June 25, 2025

    Report

    Report Number
    2016493-2025-90297
    Event Type
    Malfunction
    Date Received
    June 25, 2025
    Date of Event
    May 30, 2025
    Report Date
    June 25, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403512667
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHARMACIST
    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, 06-SEP-2012 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 HALF-HEIGHT DRAWER 5.2 WAS JAMMED AND BROKEN. A FIELD SERVICE ENGINEER FOUND THAT BOTH LEFT AND RIGHT SLIDE RAILS WERE DAMAGED. THE FSE REPLACED THE SLIDE RAILS ON BOTH SIDES TO RESTORE FUNCTIONALITY. THE FSE IDENTIFIED AN ISSUE WITH THE AUXILIARY HALF-HEIGHT DRAWER 5.2, WHERE ALL MEDICATIONS HAD BEEN UNLOADED, YET SOME WERE STILL PRESENT. TO ADDRESS THIS, THE FSE RELEASED ALL QBS, ALLOWING THE TECHNICIAN TO ACCESS THE MEDICATIONS. THE TECHNICIAN THEN RELOADED ALL DRUGS INTO DRAWER 5.2. THE FSE THEN TESTED ALL DRAWERS AND SLIDES, CHECKED CONNECTIONS, AND REMOVED DUST UNDER TOP COVER. THE CUSTOMER SUCCESSFULLY RECOVERED THE SYSTEM. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE FIELD SERVICE ENGINEER REPAIRED THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES, THE HALF-HEIGHT DRAWER 5.2 WAS JAMMED AND BROKEN. THE CUSTOMER STATED THAT THIS MALFUNCTION CAUSED A DELAY IN DISPENSING MEDICATION TO PATIENTS. HOWEVER, THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2398491 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 323 10885403512667

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown