BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES AUXILIARY

    MDR report key: 24001376 · Received January 8, 2026

    Report

    Report Number
    2016493-2025-148274
    Event Type
    Malfunction
    Date Received
    January 8, 2026
    Date of Event
    December 22, 2025
    Report Date
    December 29, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403533235
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION H MANUFACTURER NARRATIVE, SECTION B DESCRIBE EVENT OR PROBLEM, SECTION D DEVICE AVAILABLE FOR EVAL AND RETURNED TO MANUFACTURER. PART ANALYSIS: THE REPORTED CONDITION OF DRAWER 1 FAILED WAS CONFIRMED DURING FSE TESTING AND SUBSEQUENTLY CONFIRMED IN THE DCHU INSPECTION PROCESS. THE DEVICE WAS INITIALLY EVALUATED BY THE FIELD SERVICE ENGINEER (FSE) ACCORDING TO WORK ORDER (B)(4), THE FSE REPORTED THAT THE DRAWER CONTROLLER BOARD, OPEN/CLOSE SENSOR, AND SOLENOID HAD TO BE REPLACED. IT WAS FOUND THAT THE CONNECTION TO THE CONTROLLER WAS LOOSE AND SHORTED OUT. THE PARTS WERE REPLACED. THE TECHNICIAN ENTERED THE HARDWARE TESTING APPLICATION, TESTED THE SYSTEM, REBOOTED THE STATION, AND CONFIGURED IT. THE INVENTORY DRAWER IS NOW WORKING PROPERLY. DURING DCHU VISUAL INSPECTION PN 121985-01: WAS RECEIVED WITH NO SIGNS OF PHYSICAL DAMAGE, FLUID INGRESS OR MISSING COMPONENTS. PN 119579-01: WAS RECEIVED WITH SIGNS OF THERMAL DAMAGE. DN 110955-01. WAS RECEIVED WITH NO SIANS OF PHYSICAL DAMAGE. DURING DCHU TESTING PN 121985-01: FAILED THE HTA TESTING. PN 119579-01: FURTHER TESTING WAS NOT NECESSARY DUE TO THERMAL DAMAGE FOUND DURING THE EXTERNAL INSPECTION. PN 119855-01: FAILED THE HTA TESTING THE DEVICE WAS IN USE FOR TREATMENT PURPOSES AS INTENDED PER 21 CFR 820.198(D). ROOT CAUSE: THE ROOT CAUSE OF THE COMPLAINT DRAWER 1 FAILED WAS DUE TO: A FAULTY PCBA CONTROLLER BIN&FH PYXIBUS WITHOUT A SPECIFIC FAILED COMPONENT. A FAULTY "ASSY SOLENOID 6 IN LEAD MATRIX" WHICH EXHIBITED THERMAL DAMAGE IN THE COIL AND CONSEQUENTLY COMPROMISED THE PROPER OPERATION OF THE DRAWER. A FAULTY ASSY CBL SENSOR 6 IN DUE TO NOT SENSING THE DRAWER'S POSITION.

    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, 14-SEP-2023 AND CONFIRMED THAT THIS DEVICE WAS NOT PREVIOUSLY RETURNED FOR SERVICING AND THERE WERE NO PRODUCTION FAILURES WHICH CORRELATE TO THE CUSTOMER REPORTED ISSUE. UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT, IT WAS DETERMINED THAT THE SYSTEM HAD A DRAWER FAILURE. A FIELD SERVICE ENGINEER FOUND THAT THE AUXILIARY MATRIX DRAWER ONE HAD FAILED. DURING REMOTE INTERSTATION TROUBLESHOOTING WITH THE CUSTOMER, IT WAS DISCOVERED THAT THE CONNECTION ON THE CONTROLLER BOARD WAS LOOSE. THE DRAWER COULD NOT RECOVER BECAUSE THE CONTROLLER BOARD WAS DAMAGED AND NEEDED REPLACEMENT. THE FSE REPLACED THE DRAWER CONTROLLER BOARD, THE OPEN/CLOSE SENSOR, AND THE SOLENOID. IT WAS DETERMINED THAT THE LOOSE CONNECTION TO THE CONTROLLER HAD SHORTED OUT THE PARTS. AFTER REPLACEMENT, THE FSE RAN THE HARDWARE TESTING APPLICATION, TESTED THE SYSTEM, REBOOTED THE STATION, CONFIGURED IT, AND VERIFIED THAT THE INVENTORY DRAWER WAS WORKING PROPERLY. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE FIELD SERVICE ENGINEER REPAIRED THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES AUXILIARY HAD A DRAWER FAILED EVEN AFTER REBOOT AND REQUIRED MAINTENANCE THE CUSTOMER STATED THAT THEY WERE UNABLE TO ACCESS THE MEDICATION, WHICH CAUSED A DELAY TO THE PATIENT CARE. AS PER PART INVESTIGATION, IT WAS DETERMINED THAT THE DRAWER FAILURE WAS DUE TO A FAULTY PYXIBUS CONTROLLER, THERMALLY DAMAGED SOLENOID, AND A DEFECTIVE SENSOR CABLE AFFECTING DRAWER OPERATION. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES AUXILIARY HAD A DRAWER FAILED EVEN AFTER REBOOT AND REQUIRED MAINTENANCE THE CUSTOMER STATED THAT THEY WERE UNABLE TO ACCESS THE MEDICATION, WHICH CAUSED A DELAY TO THE 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
    64734 BD PYXIS¿ MEDSTATION¿ ES AUXILIARY AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002502 10885403533235

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown