BD PYXIS¿ MEDSTATION¿ ES
Report
- Report Number
- 2016493-2025-148701
- Event Type
- Malfunction
- Date Received
- January 12, 2026
- Date of Event
- December 22, 2025
- Report Date
- February 27, 2026
- Manufacturer
- CAREFUSION 303, INC.
- Product Code
- BRY
- UDI-DI
- 10885403533228
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
ADDITIONAL INFORMATION: SECTION H IMDRF ANNEX CODES. UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT, IT WAS DETERMINED THAT THE DRAWER WAS FAILED. A FIELD SERVICE ENGINEER (FSE) REPLACED THE MODULAR BOARD AND THE DRAWER BOARD. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE FIELD SERVICE ENGINEER REPAIRED THE DEVICE.
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, 08-MAY-2021 AND CONFIRMED THAT THIS DEVICE WAS NOT PREVIOUSLY RETURNED FOR SERVICING AND THERE WERE NO PRODUCTION FAILURES WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. NO FINDINGS AVAILABLE AT THE TIME THIS REPORT WAS SUBMITTED; THEREFORE, ANNEX A CODE A27 WAS APPLIED. A SUPPLEMENTAL REPORT SHALL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE REFLECTING THE APPROPRIATE MEDICAL DEVICE PROBLEM ANNEX A CODE.
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 MAIN DRAWER 6 IN 1ER AND ALL CUBIES IN DRAWER WERE NOT DETECTED ON BUS. THE CUSTOMER ATTEMPTED MULTIPLE RESETS AND PHYSICAL RECOVERY. 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 MAIN DRAWER 6 IN 1ER AND ALL CUBIES IN DRAWER WERE NOT DETECTED ON BUS. THE CUSTOMER ATTEMPTED MULTIPLE RESETS AND PHYSICAL RECOVERY. 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 MAIN DRAWER 6 IN 1ER AND ALL CUBIES IN DRAWER WERE NOT DETECTED ON BUS. THE CUSTOMER ATTEMPTED MULTIPLE RESETS AND PHYSICAL RECOVERY. 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 |
|---|---|---|---|---|---|---|---|
| 96865 | BD PYXIS¿ MEDSTATION¿ ES | AUTOMATED DISPENSING CABINET | BRY | CAREFUSION 303, INC. | 500001002500 | 10885403533228 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |