FDA Adverse Event Malfunction Summary report: N

BD PYXIS¿ ES SERVER

MDR report key: 23165588 · Received September 29, 2025

Report

Report Number
2016493-2025-118385
Event Type
Malfunction
Date Received
September 29, 2025
Date of Event
September 2, 2025
Report Date
September 9, 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 USED IN THIS INCIDENT, IT WAS DETERMINED THAT THE USER WAS UNABLE TO LOGIN TO JIT MANAGEMENT CONSOLE. THE TECHNICAL SUPPORT SPECIALIST LOGGED INTO IDM ADMIN AND SEARCHED FOR THE AFFECTED USER. THE OLD USER ACCOUNT WAS RENAMED WITH THE SUFFIX "OLD". STEPS WERE THEN PROVIDED TO THE USER FOR RE-REGISTERING THROUGH THE JIT WEB PORTAL. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST TROUBLESHOT THE DEVICE. D4 & H4: SERIAL NUMBER, UNIQUE DEVICE IDENTIFIER AND MANUFACTURER DATE NOT AVAILABLE.

Description of Event or Problem · 0

IT WAS REPORTED BY THE CUSTOMER THAT THE BD PYXIS¿ ES SERVER, THE USER WAS UNABLE TO LOGIN TO JIT MANAGEMENT CONSOLE. THE CUSTOMER STATED THAT THIS MALFUNCTION CAUSED A DELAY IN DISPENSING MEDICATION TO PATIENTS. HOWEVER, THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2145772 BD PYXIS¿ ES SERVER AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002501

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown