BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 22357115 · Received June 30, 2025

    Report

    Report Number
    2016493-2025-91383
    Event Type
    Malfunction
    Date Received
    June 30, 2025
    Date of Event
    June 3, 2025
    Report Date
    June 27, 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
    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, 07-JUL-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 MAIN HALF HEIGHT SMART DRAWER 3.2 WAS NOT DETECTED ON THE COMMUNICATION BUS. A FIELD SERVICE ENGINEER (FSE) RESEATED THE ROBO CABLE ON THE 622 BOARD, BUT THE ISSUE PERSISTED. THEN FSE REPLACED THE RETRACTOR BAND, WHICH RESOLVED THE PROBLEM. ADDITIONALLY, THE MAIN 6.1 MODULE WAS NOT DETECTED ON THE COMMUNICATION BUS. THE FSE RESEATED THE ROLL BOARD CABLE, AND THE ISSUE WAS RESOLVED. THE FSE OPENED TOP COVER AND CHECKED CONNECTIONS IN ELECTRONICS DRAWER. ADDITIONALLY, DUST BUILDUP UNDER THE TOP COVER WAS REMOVED TO ENSURE OPTIMAL FUNCTIONALITY. TESTED ALL DRAWERS AND SLIDES TO MAKE SURE THEY WERE WORKING PROPERLY. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE FIELD SERVICE ENGINEER REPAIRED THE DEVICE. E3(OTHER OCCUPATION) - PHARMACY OPERATIONS TECHNICIAN & SUPERVISOR.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT A BD PYXIS¿ MEDSTATION¿ ES HAD A DRAWER WAS FAILED AND DEVICE NOT DETECTED ON BUS. THE CUSTOMER STATED THAT THERE WAS A DELAY IN DISPENSING MEDICATION TO A PATIENT. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1219193 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 323 10885403512667

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown