FDA Adverse Event
Malfunction
Summary report: N
PYXIS MEDSTATION SYSTEM
MDR report key: 21361279
·
Received February 11, 2025
Report
- Report Number
- 2016493-2025-04056
- Event Type
- Malfunction
- Date Received
- February 11, 2025
- Date of Event
- January 14, 2025
- Report Date
- February 12, 2025
- Manufacturer
- CAREFUSION 303
- Product Code
- BRY
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT, IT WAS DETERMINED THAT ORDERS WERE NOT CROSSING IN MULTIPLE UNITS. A TECHNICAL SUPPORT SPECIALIST PRO-ACTIVELY CHECKED AND RESTARTED CCE-SERVICE AND SYSTEM. THE SERIAL NUMBER, UDI AND MANUFACTURES DETAILS KEPT BLANK SINCE THE GIVEN ASSET INFORMATION FOUND TO BE ENTERPRISE USER/FORM MGMT LIC 21-40MAINSUSER/FORM MGMT LIC 21-40MAINS. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST TROUBLESHOOTED THE DEVICE.
Description of Event or Problem · 0
IT WAS REPORTED BY THE CUSTOMER THAT PYXIS MEDSTATION ES SYSTEM ORDERS WERE NOT CROSSING IN MULTIPLE UNITS. THE CUSTOMER REPORTED THAT THERE WAS 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 |
|---|---|---|---|---|---|---|---|
| 984044 | PYXIS MEDSTATION SYSTEM | AUTOMATED DISPENSING CABINET | BRY | CAREFUSION 303 | 323 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |