BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS MEDSTATION ES

    MDR report key: 21047197 · Received December 31, 2024

    Report

    Report Number
    2016493-2024-01314
    Event Type
    Malfunction
    Date Received
    December 31, 2024
    Date of Event
    December 3, 2024
    Report Date
    March 13, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403512667
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REGULATORY REPORT IS BEING SUBMITTED DUE TO A RETROSPECTIVE REVIEW CONDUCTED THROUGH CAPA 10308384. THE LATE SUBMISSION OF THIS SUPPLEMENTAL REPORT IS DUE TO THE THOROUGH AND DETAILED NATURE OF THE RETROSPECTIVE REVIEW PROCESS. THIS PROCESS WAS ESSENTIAL TO ACCURATELY CAPTURE ALL RELEVANT DATA AND ENSURE THE INTEGRITY OF OUR REPORTING. WE HAVE INCLUDED THE CAPA REFERENCE FOR THE RETROSPECTIVE REVIEW IN THE ADDITIONAL MANUFACTURER NARRATIVE SECTION OF THE FDA FORM 3500A, AS RECOMMENDED. THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL/CORRECTED INFORMATION: B5, D1, G1, AND H6. 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 04-DEC-2022 TO 03- DEC-2024 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 STATION WAS DISPLAYING "FAILED TO STAY CLOSED ERROR". THE FIELD SERVICE ENGINEER CONDUCTED AN INSPECTION OF THE DRAWER AND DISCOVERED THAT THE MAGNET WAS MISSING FROM THE LATCH INSPECTION. THE POWER TO THE STATION WAS TURNED OFF, AND THE DRAWER WAS DISASSEMBLED IN ACCORDANCE WITH THE INSTRUCTIONS OUTLINED IN FSG SECTION 3.11.2. THE LATCH INSPECTION WAS REPLACED. DURING THE DISASSEMBLY OF THE DRAWER, THE RETRACTOR BAND CABLE WAS RECONNECTED AT BOTH THE DRAWER AND THE MODULE CONTROLLER. ADDITIONALLY, THE ROW BOARD CABLE WAS RECONNECTED TO THE DRAWER CONTROLLER. AFTER REASSEMBLING THE DRAWER, THE DEVICE WAS POWERED ON, AND THE FUNCTIONALITY OF THE DRAWER WAS VERIFIED THROUGH DIAGNOSTICS. DURING THE TESTING OF THE DRAWER A WRITING PEN WAS FOUND WHICH WAS REMOVED TO RESOLVE THE ISSUE. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE FIELD SERVICE ENGINEER TROUBLESHOOTED THE DEVICE.

    Additional Manufacturer Narrative · 0

    UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT, IT WAS DETERMINED THAT THE MALFUNCTION WAS CAUSED BY MISSING MAGNETS IN THE LATCH, WHICH COULD NOT BE SEPARATED. A FIELD SERVICE ENGINEER REPLACED THE INSEPARABLE LATCH AND RECONNECTED THE RETRACTOR BAND CABLE AT BOTH THE DRAWER AND MODULE CONTROLLER. THE ROW BOARD CABLE WAS ALSO RECONNECTED TO THE DRAWER CONTROLLER, AND THE DRAWER WAS REASSEMBLED. A FIELD SERVICE ENGINEER CONFIRMED THE FUNCTIONALITY OF THE DRAWER THROUGH DIAGNOSTICS. DURING THE TESTING OF DRAWER 6, A WRITING PEN WAS DISCOVERED, WHICH WAS REMOVED, AND THE FUNCTIONALITY OF THE DRAWER WAS SUBSEQUENTLY VERIFIED. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE FIELD SERVICE ENGINEER TROUBLESHOOTED THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD PYXIS MEDSTATION ES SYSTEM DRAWER REQUIRED MAINTENANCE AND DISPLAYED A "FAILED TO STAY CLOSED" ERROR MESSAGE. THE CUSTOMER REPORTED THAT A PEN WAS STUCK BETWEEN THE CUBIES, CAUSING THE DRAWER TO JAM. THE USERS WERE UNABLE TO ACCESS THE MEDICATIONS DUE TO THE DRAWER BEING HALTED. HOWEVER, ALL OTHER STORAGE LOCATIONS WERE AVAILABLE TO ACCESS. THERE WERE NO REPORTED ADVERSE EVENTS OR INJURIES.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE PYXIS MEDSTATION ES SYSTEM DRAWER REQUIRED MAINTENANCE AND DISPLAYED A "FAILED TO STAY CLOSED" ERROR MESSAGE. THE CUSTOMER REPORTED THAT A PEN WAS STUCK BETWEEN THE CUBIES, CAUSING THE DRAWER TO JAM. THE USERS WERE UNABLE TO ACCESS THE MEDICATIONS DUE TO THE DRAWER BEING HALTED. HOWEVER, ALL OTHER STORAGE LOCATIONS WERE AVAILABLE TO ACCESS AND CONFIRMED THAT THERE WAS NO HARM OR DELAY TO THE PATIENT AND NO DELAY. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1782717 BD PYXIS MEDSTATION ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 323 10885403512667

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown