FDA Adverse Event
Malfunction
Summary report: N
PYXIS MEDSTATION ES SYSTEM
MDR report key: 21555079
·
Received March 8, 2025
Report
- Report Number
- 2016493-2025-06852
- Event Type
- Malfunction
- Date Received
- March 8, 2025
- Date of Event
- February 11, 2025
- Report Date
- March 8, 2025
- Manufacturer
- CAREFUSION 303
- Product Code
- BRY
- UDI-DI
- 10885403512667
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT IT WAS DETERMINED THAT THE DEVICE HAD A PRINTER ISSUE. THE CUSTOMER CONFIRMED THAT THE ANALYST ONSITE AND RESOLVED. THE SYSTEM FUNCTIONED AS INTENDED AFTER TROUBLESHOT THE DEVICE.
Description of Event or Problem · 0
IT WAS REPORTED BY THE CUSTOMER THAT A PYXIS MEDSTATION SYSTEM HAD A PRINTER ISSUE. THE CUSTOMER STATED THAT MLM PRINTER CUTS AND PRINTS RIGHT SIZE WHEN FEED BUTTON PRESSED BUT NOT PRINTING PATIENT MEDICATION LABELS CAUSING A DELAY IN DISPENSING MEDICATION TO THE PATIENT. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1424294 | PYXIS MEDSTATION ES SYSTEM | AUTOMATED DISPENSING CABINET | BRY | CAREFUSION 303 | 323 | 10885403512667 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |