FDA Adverse Event Malfunction Summary report: N

BD PYXIS¿ ES SERVER

MDR report key: 23511631 · Received November 10, 2025

Report

Report Number
2016493-2025-132399
Event Type
Malfunction
Date Received
November 10, 2025
Date of Event
October 13, 2025
Report Date
October 24, 2025
Manufacturer
CAREFUSION 303, INC.
Product Code
BRY
PMA / PMN Number
EXEMPT
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
CA, US
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL
Health Professional
Yes

Narratives

Additional Manufacturer Narrative · 0

UPON INVESTIGATION OF THE ACTUAL DEVICE IN THIS INCIDENT. IT WAS DETERMINED THAT THE ORDERS WERE NOT CROSSING OVER TO STATION. A TECHNICAL SUPPORT SPECIALIST (TSS) CHECKED THE STATION AND FOUND NO ALERTS FOR PATIENTS OR ORDERS. TSS ASKED CUSTOMER IF USER HAD ANY FEEDBACK FROM HOSPITAL INFORMATION TECHNOLOGY TEAM (HIT) AND VERIFIED SSMS FOR SITE STATUS¿NO DISCONNECTIONS OR DELAYS. TSS REVIEWED PATIENT EXAMPLES IN EPHI AND CONFIRMED TWO DISCONTINUED ORDERS ON THE SERVER, WHILE TWO NEWER ORDERS FOR THE SAME PATIENT WERE MISSING. TSS RESTARTED SEVERAL SERVICES AND ESCALATED TO IEST TO VERIFY MESSAGES IN CAREFUSION COORDINATION ENGINE (CCE). THE TSS DIALED INTO CCE, FOUND TWO SOLUTIONS, AND RESTARTED THE CCE-SERVICE FOR MED. WHILE ON THE CALL, USAGE DROPPED, SUGGESTING HIT WAS MAKING PROGRESS, BUT AFTER DISCONNECTING, TSS WAS UNABLE TO PING. THE TSS RESTARTED THE CCE-SERVICE AGAIN ON THE MED SOLUTION; STILL NO INBOUND ADT/RDE. TSS AFTER REFRESHING THE MESSAGE TRACE, ACTIVE DIRECTORY AND RDE MESSAGES BEGAN CROSSING FROM RX CONNECT. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST TROUBLESHOT THE DEVICE. D4 & H4: SERIAL NUMBER, CATALOG, MODEL, UNIQUE DEVICE IDENTIFIER AND MANUFACTURER DATE NOT AVAILABLE.

Description of Event or Problem · 0

IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ ES SERVER ORDERS WERE NOT CROSSING OVER TO STATION. THE CUSTOMER STATED THAT THERE WAS A DELAY IN PATIENT CARE. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED DUE TO THIS EVENT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1854107 BD PYXIS¿ ES SERVER AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC.

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown SN: (B)(6) LOCATION: (B)(6)