BD PYXIS¿ MEDSTATION¿ ES
Report
- Report Number
- 2016493-2025-144486
- Event Type
- Malfunction
- Date Received
- December 18, 2025
- Date of Event
- December 9, 2025
- Report Date
- December 20, 2025
- Manufacturer
- CAREFUSION 303, INC.
- Product Code
- BRY
- UDI-DI
- 10885403533228
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHARMACIST
- Health Professional
- Yes
Narratives
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, 18-MAY-2023 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 THIS INCIDENT, A TECHNICAL SUPPORT SPECIALIST (TSS) STATED THAT THE PHENOMENON DESCRIBED WAS POSSIBLY RELATED TO THE USER NOT HAVING ACCESS TO THE AREA ASSIGNED TO THE STATION. TSS ADVISED TO CHECK THE DEVICE SETTINGS (DEVICE SELECT RER PSYCH VERIFY AREAS ASSIGNED) AND ENSURE AT LEAST ONE AREA WAS ASSIGNED TO THE DEVICE. TSS ALSO INSTRUCTED TO REVIEW USER PERMISSIONS FOR THAT AREA TO CONFIRM ACCESS RIGHTS. TSS EXPLAINED THAT IF THE DEVICE HAD NO AREA ASSIGNED, IT WOULD CAUSE ISSUES FOR ALL USERS. TSS REQUESTED CONFIRMATION IF THIS RESOLVED THE ISSUE AND USER REQUESTED TO CLOSE THE CASE. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST ASSISTED THE CUSTOMER.
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 MULTIPLE BUTTONS WERE MISSING ON THE MAIN SCREEN AND UNABLE TO ACCESS MEDICATION. THE CUSTOMER REPORTED 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 MULTIPLE BUTTONS WERE MISSING ON THE MAIN SCREEN AND UNABLE TO ACCESS MEDICATION. THE CUSTOMER REPORTED 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 |
|---|---|---|---|---|---|---|---|
| 2246261 | BD PYXIS¿ MEDSTATION¿ ES | AUTOMATED DISPENSING CABINET | BRY | CAREFUSION 303, INC. | 500001002500 | 10885403533228 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |