FDA Adverse Event Malfunction Summary report: N

BD PYXIS¿ ES SERVER

MDR report key: 25093255 · Received May 6, 2026

Report

Report Number
2016493-2026-26333
Event Type
Malfunction
Date Received
May 6, 2026
Date of Event
April 8, 2026
Report Date
May 14, 2026
Manufacturer
CAREFUSION 303, INC.
Product Code
BRY
PMA / PMN Number
EXEMPT
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
PA, US
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL
Health Professional
Yes

Narratives

Additional Manufacturer Narrative · 0

D.4: UNIQUE DEVICE IDENTIFIER 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 CUSTOMER WAS PREPARING FOR A (B)(6) REGISTRATION CONVERSION FROM (B)(6) FOR ((B)(6) FACILITIES: (B)(6) HOSPITAL AND (B)(6)). THE CONVERSION WAS SCHEDULED TO BEGIN ON THE EARLY MORNING AT 4:00 AM PDT ON APRIL 25TH, WITH CONNECTIVITY TESTING EXPECTED BETWEEN 5:00 AM AND 8:00 AM PDT. DURING THIS WINDOW, (B)(6) AND FACILITY RESOURCES WOULD VALIDATE THAT (B)(6) WERE PROCESSING CORRECTLY POST-CONVERSION. 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
445262 BD PYXIS¿ ES SERVER AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002501

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown GENERIC MEDSTATION ES.