BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PYXIS¿ MEDSTATION¿ ES AUXILIARY

    MDR report key: 22204084 · Received June 13, 2025

    Report

    Report Number
    2016493-2025-87111
    Event Type
    Malfunction
    Date Received
    June 13, 2025
    Date of Event
    May 19, 2025
    Report Date
    June 12, 2025
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BRY
    UDI-DI
    10885403512681
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHARMACIST
    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, 31-JAN-2023 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 INCIDENT, IT WAS DETERMINED THAT THE PATIENT INFORMATION WAS NOT CROSSED OVER. A TECHNICAL SUPPORT SPECIALIST DIALED INTO THE CCE ENVIRONMENT AND RESTARTED THE CCE-SERVICE TO REESTABLISH COMMUNICATION AND CONFIRMED THAT ADT AND RDE MESSAGES WERE SUCCESSFULLY CROSSING TO THE ES SERVER AND THE RECURRING NATURE OF THE ISSUE, IT APPEARED MOST LIKELY THAT AN ENVIRONMENTAL FACTOR HAD BEEN INTERMITTENTLY INTERRUPTING THE CONNECTION BETWEEN THE TWO HOSTS. THE TSS HAS BEEN WAITING FOR CUSTOMER RESPONSE BUT THERE WAS NO RESPONSE RECEIVED FROM CUSTOMERS RELATED TO FURTHER ASSISTANCE. SO, THE TECHNICAL SUPPORT SPECIALIST HAS CLOSED THE CASE.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT A BD PYXIS¿ MEDSTATION¿ ES AUXILIARY HAD PATIENT INFORMATION THAT WAS NOT CROSSING OVER. THE CUSTOMER STATED THAT THERE WAS A DELAY IN DISPENSING MEDICATION TO A PATIENT. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552496 BD PYXIS¿ MEDSTATION¿ ES AUXILIARY AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 324 10885403512681

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown