FDA Adverse Event Malfunction Summary report: N

BD PYXIS¿ MEDSTATION¿ ES

MDR report key: 23892116 · Received December 25, 2025

Report

Report Number
2016493-2025-145802
Event Type
Malfunction
Date Received
December 25, 2025
Date of Event
December 15, 2025
Report Date
December 18, 2025
Manufacturer
CAREFUSION 303, INC.
Product Code
BRY
UDI-DI
10885403533228
PMA / PMN Number
EXEMPT
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
VA, US
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL
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, 30-NOV-2010 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, IT WAS DETERMINED THAT STATION HAD INVALID MULTI-COMPONENT ORDER ERROR. THE TECHNICAL SUPPORT SPECIALIST (TSS) FOLLOWED THE KNOWLEDGE ARTICLE "MULTI-COMPONENT ORDER TROUBLESHOOTING" AND IDENTIFIED THE ISSUE USING USER LATEST EXAMPLE. THE MED ID (B)(6) HAD A COMBO MEDICATION ASSIGNED, WHICH IS NOT ALLOWED FOR MULTI-COMPONENT ORDERS. THE TSS SENT AN EMAIL TO USER WITH GUIDANCE ON TROUBLESHOOTING MULTI-COMPONENT ORDERS. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST TROUBLESHOT THE ISSUE.

Description of Event or Problem · 0

IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES, ERROR MESSAGE WAS POPULATING WHEN USER ATTEMPTING TO REMOVE MULTI COMPONENT ORDER CONTAINING MED IDENTIFICATION NUMBERS. THE CUSTOMER STATED THAT THIS MALFUNCTION OCCURRED WHILE DISPENSING THE MEDICATION AND CAUSED A DELAY TO THE 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
2319483 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002500 10885403533228

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown