BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES

    MDR report key: 25200874 · Received May 18, 2026

    Report

    Report Number
    2016493-2026-29908
    Event Type
    Malfunction
    Date Received
    May 18, 2026
    Date of Event
    April 21, 2026
    Report Date
    April 30, 2026
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403533228
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    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, 28-SEP-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 DATA SYNCHRONIZATION LOGS CONFIRMED THAT STATION WAS IN MANUAL RECOVERY MODE. A TECHNICAL SUPPORT SPECIALIST (TSS) FOLLOWED KNOWLEDGE ARTICLE (KA) " MANUAL RECOVERY REQUIRED - DATASYNCINVALIDUPLOADCHANGETRACKINGVALUE" TO RESOLVE THE ISSUE. SUBSEQUENTLY, RETRY ERRORS WERE ENCOUNTERED, STARTING WITH AN INSERT INTO TX. ENCOUNTERITEMTRANSACTION QUERY, WHICH WAS ADDRESSED BY ENDING THE ACTIVE ENCOUNTERPATIENTLOCATIONKEY AS PER KA "MEDSTATION ES-RETRY MODE: INSERT INTO TX. ENCOUNTERITEMTRANSACTION-MISMATCHING ADT.ENCOUNTERPATIENTLOCATIONKEY". FURTHER RETRIES RELATED TO ADT.ENCOUNTERPATIENTLOCATION WERE OBSERVED, AND IN THE ABSENCE OF A DIRECT KA, A PREVIOUS PRODUCT SUPPORT ENGINEER (PSE) CONSULT WAS REFERENCED; HOWEVER, APPLYING THE MANUAL RECOVERY SCRIPT DID NOT RESOLVE THE ISSUE. A NEW PSE CONSULT WAS CREATED, AND ALL RETRY ENTRIES WITH DIFFERENT ENCOUNTERPATIENTLOCATIONKEYS WERE SYSTEMATICALLY CLEARED. ONCE ALL RETRIES WERE RESOLVED, THE STATION RESUMED UPLOADING SUCCESSFULLY, AND A NO VARIATION STATUS WAS CONFIRMED. AS A FINAL STEP, A NEW DATABASE BACKUP WAS CREATED AND SAVED, FOLLOWED BY PERFORMING A FULL SYNCHRONIZATION OF THE STATION TO ENSURE STABILITY. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST TROUBLESHOT THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES MED_ER STATION WAS ON RETRY MODE. 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
    271620 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002500 10885403533228

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown