BD PYXIS¿ MEDSTATION¿ ES
Report
- Report Number
- 2016493-2026-08835
- Event Type
- Malfunction
- Date Received
- February 24, 2026
- Date of Event
- January 29, 2026
- Report Date
- April 15, 2026
- Manufacturer
- CAREFUSION 303, INC.
- Product Code
- BRY
- UDI-DI
- 10885403533228
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, 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, 07-OCT-2016 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.
ADDITIONAL INFORMATION: SECTION H IMDRF ANNEX CODES AND MANUFACTURER NARRATIVE. UPON INVESTIGATION OF THIS INCIDENT, A FIELD SERVICE ENGINEER (FSE) CONFIRMED THAT THE ISSUE WAS RESOLVED BY THE CUSTOMER BY REPLACED THE INTERNAL BATTERY, AND NO FURTHER INVESTIGATION WAS REQUIRED. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE CUSTOMER RESOLVED THE ISSUE.
IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES, DEVICE NOT COMMUNICATING AND CUSTOMER REPORTED BATTERY POWER FAILURE MANAGER. ONE DEVICE WAS REPEATEDLY REBOOTING, PREVENTING CLINICAL STAFF FROM ACCESSING MEDICATIONS. 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, DEVICE NOT COMMUNICATING AND CUSTOMER REPORTED BATTERY POWER FAILURE MANAGER. ONE DEVICE WAS REPEATEDLY REBOOTING, PREVENTING CLINICAL STAFF FROM ACCESSING MEDICATIONS. 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, DEVICE NOT COMMUNICATING AND CUSTOMER REPORTED BATTERY POWER FAILURE MANAGER. ONE DEVICE WAS REPEATEDLY REBOOTING, PREVENTING CLINICAL STAFF FROM ACCESSING MEDICATIONS. 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 |
|---|---|---|---|---|---|---|---|
| 327951 | BD PYXIS¿ MEDSTATION¿ ES | AUTOMATED DISPENSING CABINET | BRY | CAREFUSION 303, INC. | 500001002500 | 10885403533228 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |