FDA Adverse Event Malfunction Summary report: N

BD PYXIS¿ MEDSTATION¿ ES

MDR report key: 24542745 · Received March 9, 2026

Report

Report Number
2016493-2026-11938
Event Type
Malfunction
Date Received
March 9, 2026
Date of Event
February 14, 2026
Report Date
February 17, 2026
Manufacturer
CAREFUSION 303, INC.
Product Code
BRY
UDI-DI
10885403533228
PMA / PMN Number
EXEMPT
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
FL, 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, 28-OCT-2015 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 THE DRAWER ISSUE. A FIELD SERVICE ENGINEER (FSE) INSPECTED THE MAIN FULL HEIGHT LEGACY DRAWER SIX, ROW EIGHT, AND FOUND THAT THE QBS WERE NOT DETECTED ON THE BUS. ALL LEDS WERE PRESENT ON THE ROLL BOARD. UPON MANUALLY REMOVING THE QBS, LIQUID WAS DISCOVERED UNDER ROW A. THE ROW BOARD A WAS REPLACED, AND THE ISSUE WAS RESOLVED. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE FIELD SERVICE ENGINEER REPAIRED THE DEVICE.

Description of Event or Problem · 0

IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES DRAWER 6 INVOLVING THE CUBIES IN THE FIRST ROW (ROW A) HAD ISSUES. UPON INSPECTION, LIQUID WAS FOUND BENEATH THE CUBIES, WHICH HAD MADE CONTACT WITH THE BOARD UNDER THE ROW. THE AREA WAS CLEANED, BUT THE ROW REMAINS NONFUNCTIONAL AND MAY REQUIRE REPLACEMENT. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
606007 BD PYXIS¿ MEDSTATION¿ ES AUTOMATED DISPENSING CABINET BRY CAREFUSION 303, INC. 500001002500 10885403533228

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown