BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES TOWER

    MDR report key: 24940373 · Received April 21, 2026

    Report

    Report Number
    2016493-2026-22834
    Event Type
    Malfunction
    Date Received
    April 21, 2026
    Date of Event
    March 25, 2026
    Report Date
    March 31, 2026
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403512674
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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, 26-AUG-2025 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 BIO ID WAS NOT WORKING. A TECHNICAL SUPPORT (TSS) DIALED INTO STATION AND FOLLOWED KNOWLEDGE ARTICLE "BIOID SENSOR FAILS AFTER PUSHING RSS ES 1.8 LUMIDIGM UPDATE" TO UNINSTALL THE OLD LUMIDVCSVC, THEN DOWNLOADED, INSTALLED, AND REINSTALLED THE BIO ID DRIVER MULTIPLE TIMES, BUT ENCOUNTERED SERVICE ERRORS, INTERNAL LUMI SDK ERRORS, AND NO BIO ID DETECTION IN HTA AND AFTER CONTINUED FAILURES, TSS DISPATCHED A FIELD SERVICE ENGINEER (FSE) TO REPLACE THE BIO ID HARDWARE. AFTER FSE REPLACING THE BIO ID STILL STATION COULD NOT DETECT BIO ID IN HARDWARE TEST APPLICATION (HTA) AND ESCALATED AGAIN TO TSS. LATER TSS ASSISTED WITH REMOVING RESIDUAL OLD LUMIDIGM COMPONENTS FROM THE REGISTRY AND PROGRAM FILES, THE DRIVER WAS REINSTALLED PER THE SAME KNOWLEDGE ARTICLE, THE STATION WAS REBOOTED, BIO ID WAS SUCCESSFULLY DETECTED IN HTA. FSE THEN PROCEEDED TO REPLACE THE BIO ID UNIVERSAL SERIAL BUS CABLE TO ELIMINATE A POSSIBLE SOURCE OF FAILURE, AND THE CUSTOMER WAS NOTIFIED THAT CONFIRMED THAT THE BIO ID ISSUE WAS RESOLVED. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST AND TROUBLESHOT AND FIELD SERVICE ENGINEER REPAIRED THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES TOWER BIOMETRIC IDENTIFIER WAS NOT WORKING PROPERLY AND ERROR MESSAGE DISPLAYED REQUIRED MAINTENANCE. THE CUSTOMER STATED THAT THERE WAS 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
    270616 BD PYXIS¿ MEDSTATION¿ ES TOWER AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002506 10885403512674

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown