FDA Adverse Event Malfunction Summary report: N

BD PYXIS¿ ES SERVER

MDR report key: 25241603 · Received May 21, 2026

Report

Report Number
2016493-2026-30938
Event Type
Malfunction
Date Received
May 21, 2026
Date of Event
April 25, 2026
Report Date
May 4, 2026
Manufacturer
CAREFUSION 303, INC.
Product Code
BRY
PMA / PMN Number
EXEMPT
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
CA
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL
Health Professional
Yes

Narratives

Additional Manufacturer Narrative · 0

D.4 & H.4: SERIAL NUMBER, UNIQUE DEVICE IDENTIFIER, AND MANUFACTURER DATE NOT AVAILABLE. UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT, IT WAS DETERMINED THAT THE STATIONS HAD AN INCORRECT TIME. A TECHNICAL SUPPORT SPECIALIST (TSS) REPORTED THAT REMOTE ACCESS WAS ESTABLISHED TO THE STATION, THE COMMAND SHELL WAS OPENED, AND THE STATION TIME WAS CORRECTED ACCORDING TO THE REFERENCED KNOWLEDGE ARTICLE TITLED "DEVICE TIME IS INCORRECT". THE TSS CONFIRMED THAT THE STATION TIME WAS SYNCHRONIZED WITH THE SERVER TIME AND THEN PROCEEDED TO APPLY THE SAME CORRECTION TO THE REMAINING AFFECTED STATIONS TO RESOLVE THE ISSUE. 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¿ ES SERVER USER INFORMED INCORRECT TIME WAS DISPLAYED ON THE FOLLOWING MEDSTATIONS: PX-S-5E1, PX-S-5E2, AND PX-S-5ESCU. HOWEVER, THERE WERE NO DELAYS OR ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
452273 BD PYXIS¿ ES SERVER AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC.

Patients

Seq Age Sex Outcome Treatment
1