BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES AUXILIARY TOWER

    MDR report key: 24981850 · Received April 24, 2026

    Report

    Report Number
    2016493-2026-23791
    Event Type
    Malfunction
    Date Received
    April 24, 2026
    Date of Event
    March 28, 2026
    Report Date
    March 31, 2026
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403512698
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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, 21-NOV-2014 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 TOWER DOOR 2 WAS FAILED. THE FIELD SERVICE ENGINEER (FSE) VERIFIED THAT THERE WERE NO APPLICATION FAILURES AND WAS POWERED DOWN THE MACHINE. THE FSE REPLACED ALL FOUR TOWER DOOR LATCHES TO RESOLVE. FINAL TESTING WAS COMPLETED IN HARDWARE TEST APPLICATION, AND THE CUSTOMER WAS ABLE TO OPEN TOWER DOOR 2 SUCCESSFULLY WITH NO FURTHER ISSUES. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE FIELD SERVICE ENGINEER (FSE) REPAIRED THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES AUXILIARY TOWER, NWP-LD1 DRAWER AND DOOR FAILED. THE CUSTOMER STATED THAT THIS MALFUNCTION OCCURRED WHILE DISPENSING THE MEDICATION AND THEY HAD TO ACCESS THE MEDICATIONS FROM ANOTHER STATION THAT CAUSED 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
    591115 BD PYXIS¿ MEDSTATION¿ ES AUXILIARY TOWER AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002502 10885403512698

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SN: (B)(6), LOCATION: NWP-LD1