BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ ES SERVER

    MDR report key: 24589468 · Received March 13, 2026

    Report

    Report Number
    2016493-2026-13665
    Event Type
    Malfunction
    Date Received
    March 13, 2026
    Date of Event
    February 17, 2026
    Report Date
    March 17, 2026
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SECTION H IMDRF ANNEX CODES. UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT, IT WAS DETERMINED THAT THE MULTIPLE REPLENISHMENT WAS NOT CROSSING OVER TO THE LOGISTIC. A TECHNICAL SUPPORT SPECIALIST VERIFIED THAT SOME MEDICATIONS WERE CROSSING SUCCESSFULLY FOR THE AFFECTED STATION; HOWEVER, THE LOGISTICS SYSTEM WAS NOT SHOWING RECEIPT OF THE REPLENISHMENT ORDER, SO THE INTERFACE TEAM WAS REQUESTED TO VERIFY WHETHER THE ORDER WAS VISIBLE ON THEIR SIDE. THE TSS NOTED THAT THE CUSTOMER ALSO REPORTED SIMILAR ISSUES WITH MEDICATIONS FROM ANOTHER DEVICE, INDICATING THAT MULTIPLE MEDICATIONS AND STATIONS WERE AFFECTED, ALTHOUGH SOME REPLENISHMENTS HAD CROSSED SUCCESSFULLY; UPON REMOTELY ACCESSING THE CAREFUSION COORDINATION ENGINE (CCE), IT WAS CONFIRMED THAT THE LAKE PLACID TRIGGER, WHICH INCLUDED THE STATIONS WAS CONFIGURED TO RUN ON MONDAYS AND THURSDAYS, WITH PRESIDENTS DAY SET AS A NO ORDER HOLIDAY, EXPLAINING WHY THE TRIGGER DID NOT RUN ON THAT DAY, AND AFTER CONFIRMING THAT THE TRIGGER OPERATED AS CONFIGURED AND REVIEWING THE CONFIGURED NO ORDER HOLIDAYS WITH THE CUSTOMER, APPROVAL WAS GIVEN TO MARK THE CASE AS COMPLETED. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST INVESTIGATED THE ISSUE.

    Additional Manufacturer Narrative · 0

    D4 & H4: SERIAL NUMBER, UNIQUE DEVICE IDENTIFIER (UDI) AND MANUFACTURER DATE NOT AVAILABLE. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ ES SERVER, MULTIPLE REPLENISHMENT WAS NOT CROSSING OVER TO LOGISTIC. THE CUSTOMER STATED THAT THIS MALFUNCTION OCCURRED WHILE DISPENSING THE MEDICATION, AND THEY WERE UNABLE TO ISSUE THE MEDICATION, WHICH RESULTED IN A DELAY IN PATIENT CARE. 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¿ ES SERVER, MULTIPLE REPLENISHMENT WAS NOT CROSSING OVER TO LOGISTIC. THE CUSTOMER STATED THAT THIS MALFUNCTION OCCURRED WHILE DISPENSING THE MEDICATION, AND THEY WERE UNABLE TO ISSUE THE MEDICATION, WHICH RESULTED IN 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
    31470 BD PYXIS¿ ES SERVER AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SN: (B)(6) LOCATION: IT.| SN: (B)(6) LOCATION: LKPER.| SN: (B)(6) LOCATION: LKPMSU.