BD PYXIS¿ MEDSTATION¿ ES
Report
- Report Number
- 2016493-2025-121299
- Event Type
- Malfunction
- Date Received
- October 9, 2025
- Date of Event
- September 15, 2025
- Report Date
- April 7, 2026
- Manufacturer
- CAREFUSION 303, INC.
- Product Code
- BRY
- UDI-DI
- 10885403533228
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHARMACIST
- Health Professional
- Yes
Narratives
ADDITIONAL INFORMATION: SECTION H MANUFACTURER NARRATIVE. CORRECTION: SECTION D UNIQUE IDENTIFIER (UDI). PART ANALYSIS: THE REPORTED ISSUE RELATED TO THE MEDSTATION ES MAIN 6-DRAWER WAS CONFIRMED BY THE BD FSE. THE DEVICE WAS INITIALLY EVALUATED BY THE BD FSE ACCORDING TO WO 02102896: EVEN THOUGH THE CUSTOMER REPORTED TWO ISSUED DRAWERS, FSE ONLY REPORTED INSPECTION AND TESTING OF ONE DRAWER. FSE REPORTED THAT MED SPILLED INSIDE THE FH DRAWER WAS FOUND UPON ARRIVAL. FSE WIPED CLEAN ALL POCKETS AND CUBIE TRAYS. FSE REPLACED THE ISSUED FH CUBIE BUS MODULE AND DRAWER CONTROLLER BOARDS, BUT STILL UNABLE TO RECOVER FAILED POCKETS AND THE ISSUED PERSISTED. FSE DECIDED TO REPLACE THE WHOLE FH DRAWER. THE DEVICE WAS THEN CONFIGURATED AND TESTED AND EXHIBITED NO FURTHER ISSUES. EXTERNAL INSPECTION FOUND NO OBVIOUS PHYSICAL DAMAGE, DEFORMATION, OR CONTAMINATION ON THE DRAWER HOUSING, LATCH MECHANISM, OR CONNECTOR INTERFACE OF THE RETURNED ASSY CUBIE MODULE FH (P/N 138900-02). DCHU TESTING DETERMINED THAT THE DRAWER ISSUES WERE MOST LIKELY DUE TO THE SPILLED MEDS FOUND BY FSE. THE DEVICE WAS IN USE FOR TREATMENT PURPOSES AS INTENDED PER 21 CFR 820.198(D). ROOT CAUSE: THE ROOT CAUSE WAS NOT DETERMINED. THE DRAWER WAS OBSERVED TO BOTH OPEN AND LOCK. THE PROBABLE CAUSE OF THE DRAWER ISSUES IS MOST LIKELY DUE TO THE SPILLED MEDS THAT WAS OBSERVED BY THE FSE INSIDE THE DRAWER.
ADDITIONAL INFORMATION: SECTION H IMDRF ANNEX CODES 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, 20-JUN-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, IT WAS DETERMINED THAT THE DRAWER FAILED. A FIELD SERVICE ENGINEER INSPECTED THE DEVICE AND FOUND MEDICATION SPILL IN CUBIE DRAWER, CLEANED TRAYS, REPLACED BUS MODULE AND CONTROLLER BOARDS. ISSUE PERSISTED REPLACED ENTIRE DRAWER FROM INVENTORY, MOVED CUBIE POCKETS, CONFIGURED IN MED APPLICATION, AND TESTED SUCCESSFULLY. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE FIELD SERVICE ENGINEER REPAIRED THE DEVICE.
A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES, THE DRAWERS FAILED AND REQUIRED MAINTENANCE. THE CUSTOMER REPORTED THAT THERE WAS A DELAY IN DISPENSING THE MEDICATION. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.
IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES, THE DRAWERS FAILED AND REQUIRED MAINTENANCE. THE CUSTOMER REPORTED THAT THERE WAS A DELAY IN DISPENSING THE MEDICATION. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.
IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES, THE DRAWERS FAILED AND REQUIRED MAINTENANCE. THE CUSTOMER REPORTED THAT THERE WAS A DELAY IN DISPENSING THE MEDICATION. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2446492 | BD PYXIS¿ MEDSTATION¿ ES | AUTOMATED DISPENSING CABINET | BRY | CAREFUSION 303, INC. | 500001002500 | 10885403533228 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |