FDA Adverse Event
Malfunction
Summary report: N
PYXIS MEDSTATION ES SYSTEM
MDR report key: 21580546
·
Received March 12, 2025
Report
- Report Number
- 2016493-2025-07777
- Event Type
- Malfunction
- Date Received
- March 12, 2025
- Date of Event
- February 13, 2025
- Report Date
- March 12, 2025
- Manufacturer
- CAREFUSION 303
- Product Code
- BRY
- UDI-DI
- 10885403512667
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHARMACIST
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT, IT WAS DETERMINED THAT THE FULL HEIGHT DRAWER WAS FAILED. THE FIELD SERVICE ENGINEER FOUND THE ROWBOARD E HAS BROKEN CLIP INSIDE, HENCE REPLACED THE ROW BOARD TO RESOLVE THE ISSUE. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE FIELD SERVICE ENGINEER TROUBLESHOT THE DEVICE.
Description of Event or Problem · 0
IT WAS REPORTED WHEN USING THE BD PYXIS MEDSTATION SYSTEM THAT THE FULL HEIGHT DRAWER WAS FAILED. THE CUSTOMER STATED THAT THIS MALFUNCTION CAUSED A DELAY TO THE PATIENT. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 926314 | PYXIS MEDSTATION ES SYSTEM | AUTOMATED DISPENSING CABINET | BRY | CAREFUSION 303 | 323 | 10885403512667 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |