BD PYXIS¿ MEDSTATION¿ ES
Report
- Report Number
- 2016493-2025-141310
- Event Type
- Malfunction
- Date Received
- December 8, 2025
- Date of Event
- November 20, 2025
- Report Date
- April 16, 2026
- Manufacturer
- CAREFUSION 303, INC.
- Product Code
- BRY
- UDI-DI
- 10885403533228
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
ADDITIONAL INFORMATION: SECTION H IMDRF ANNEX CODES. PART ANALYSIS: THE REPORTED CONDITION OF FAILED DRAWER WAS CONFIRMED BY FSE AND SUBSEQUENTLY CONFIRMED IN THE DCHU INSPECTION PROCESS. ACCORDING TO WORK ORDER # (B)(4), THE FSE REPORTED THAT MAIN FULL HEIGHT DRAWER 4 WAS NOT DETECTED ON BUS. THE DRAWER AND POCKETS WERE LISTED AS NOT DETECTED ON BUS. THE FSE REMOVED IT AND FOUND NO LIGHTS ON THE MODULE CONTROL BOARD. THE FSE SHUT DOWN THE STATION AND RESEATED ALL CABLE CONNECTIONS ON THE BACK ON THE DRAWER. THE FSE REPLACED PYXIBUS MODULE CONTROLLER BOARD. THE FSE RAN THE HTA FINAL TEST TOOL WITH NO ISSUES. DURING DCHU VISUAL INSPECTION: P/N 151903-01: WAS RECEIVED WITH SIGNS OF THERMAL DAMAGE ON COMPONENT U300 AND CAPACITORS C302. DURING DCHU TESTING: P/N 151903-01: THE TESTING FROM DCHU WAS NOT NECESSARILY DUE TO THE SIGNS OF THERMAL ON THE INTERNAL COMPONENTS OF THE PCBA. THE DEVICE WAS IN USE FOR TREATMENT PURPOSES AS INTENDED PER 21 CFR 820.198(D). ROOT CAUSE: THE ROOT CAUSE WAS IDENTIFIED AS THERMAL DAMAGE TO COMPONENT U300 AND CAPACITORS C302 ON THE FULL HEIGHT CUBIE PMC (P/N 151903-01) CIRCUIT BOARD RESULTING FROM AN ELECTRICAL FAILURE. THIS DAMAGE COMPROMISED THE COMMUNICATION AND CONTROL SIGNALS RESPONSIBLE FOR MANAGING THE CUBIE POCKETS, LEADING TO THEIR MALFUNCTION.
A REVIEW OF THE COMPLAINT HISTORY FOR (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 (B)(6) WAS PERFORMED FROM THE DATE OF MANUFACTURE, 14-JUL-2018 AND CONFIRMED THAT THIS DEVICE WAS NOT PREVIOUSLY RETURNED FOR SERVICING AND THERE WERE NO PRODUCTION FAILURES WHICH CORRELATE TO THE CUSTOMER REPORTED ISSUE. UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT, IT WAS DETERMINED THAT THE MAIN FULL HEIGHT DRAWER 4 WAS NOT DETECTED ON THE BUS, AND ALSO THAT THE DRAWER AND POCKETS WERE LISTED AS NOT DETECTED ON THE BUS. A FIELD SERVICE ENGINEER REMOVED THE BACK AND FOUND NO LIGHTS ON THE MODULE CONTROL BOARD, SUBSEQUENTLY SHUTTING DOWN THE STATION. FSE RESEATED ALL CABLE CONNECTIONS ON THE BACK OF THE DRAWER, REPLACED THE PYXIBUS MODULE CONTROLLER BOARD, RESTARTED THE STATION, AND LOGGED INTO THE HARDWARE TEST APPLICATION. THE HARDWARE TESTING APPLICATION FINAL TEST TOOL WAS RUN WITHOUT ANY ISSUES, AND THE STATION WAS RESEATED. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE FIELD SERVICE ENGINEER REPAIRED THE DEVICE.
IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES DRAWER WAS FAILED AND NOT DETECTED ON BUS. AS PER PART INVESTIGATION, IT WAS DETERMINED THAT THERE WAS THERMAL DAMAGE OBSERVED ON THE PCBA COMPONENT U300 AND CAPACITORS C302 WERE FOUND. THE CUSTOMER STATED THAT THERE WAS A DELAY IN PATIENT CARE. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.
IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES DRAWER WAS FAILED AND NOT DETECTED ON BUS. 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 |
|---|---|---|---|---|---|---|---|
| 623072 | BD PYXIS¿ MEDSTATION¿ ES | AUTOMATED DISPENSING CABINET | BRY | CAREFUSION 303, INC. | 500001002500 | 10885403533228 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |