FDA Adverse Event Malfunction Summary report: N

BD PYXIS¿ MEDSTATION¿ ES

MDR report key: 24466592 · Received February 27, 2026

Report

Report Number
2016493-2026-09631
Event Type
Malfunction
Date Received
February 27, 2026
Date of Event
February 3, 2026
Report Date
February 9, 2026
Manufacturer
CAREFUSION 303, INC.
Product Code
BRY
UDI-DI
10885403533228
PMA / PMN Number
EXEMPT
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
GA, 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, 18-MAY-2018 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 ACTUAL DEVICE USED IN THIS INCIDENT, A TECHNICAL SUPPORT SPECIALIST (TSS) VERIFIED THE DATA BASE SYNCHRONIZATION LOGS AND NO ERRORS WERE FOUND. TSS CONFIRMED THAT THERE WERE NO ISSUES WITH THE DEVICE, AND NO FURTHER INVESTIGATION WAS REQUIRED. CUSTOMER CONFIRMED THAT THE CASE WAS RESOLVED. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST INVESTIGATED THE ISSUE.

Description of Event or Problem · 0

IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES, ED PATIENT WAS NOT CROSSING OVER FROM EPIC TO PYXIS. THE CUSTOMER STATED THAT THERE WAS A DELAY IN PATIENT CARE. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
528505 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002500 10885403533228

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown