BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES AUXILIARY

    MDR report key: 21669057 · Received March 21, 2025

    Report

    Report Number
    2016493-2025-08577
    Event Type
    Malfunction
    Date Received
    March 21, 2025
    Date of Event
    February 25, 2025
    Report Date
    March 21, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403512681
    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

    UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT, IT WAS DETERMINED THAT FULL-HEIGHT CUBIE DRAWER 7 FAILED TO DETECT ON THE BUS. A FIELD SERVICE ENGINEER DISASSEMBLED THE DRAWER IN ACCORDANCE WITH THE GUIDELINES OUTLINED IN FSG SECTION 3.11.2. THE ENGINEER REPLACED THE LATCH INSPECTION AND, WHILE THE DRAWER WAS DISASSEMBLED, RECONNECTED THE RETRACTOR BAND CABLE AT BOTH THE DRAWER AND THE MODULE CONTROLLER. ADDITIONALLY, THE ROW BOARD CABLE WAS RECONNECTED AT THE DRAWER CONTROLLER AND THE INDIVIDUAL ROW BOARDS. DURING THE INSPECTION OF THE MODULE CONTROLLER, THE ENGINEER DISCOVERED RESIDUE FROM A DAMAGED ELECTRONIC COMPONENT, PROMPTING THE REPLACEMENT OF THE MODULE CONTROLLER. AFTER REASSEMBLING THE DRAWER, THE ISSUE WAS RESOLVED. A FIELD SERVICE ENGINEER ALSO CONFIRMED THAT THERE WAS A DELAY IN DISPENSING MEDICATION TO THE PATIENT. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE FIELD SERVICE ENGINEER TROUBLESHOT THE ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES, AUXILIARY DRAWER FAILED AND WAS NOT DETECTED ON THE COMMUNICATION BUS. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1424502 BD PYXIS¿ MEDSTATION¿ ES AUXILIARY AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 324 10885403512681

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown