FDA Adverse Event
Malfunction
Summary report: N
BD PYXIS¿ ES SERVER
MDR report key: 25093255
·
Received May 6, 2026
Report
- Report Number
- 2016493-2026-26333
- Event Type
- Malfunction
- Date Received
- May 6, 2026
- Date of Event
- April 8, 2026
- Report Date
- May 14, 2026
- Manufacturer
- CAREFUSION 303, INC.
- Product Code
- BRY
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
D.4: UNIQUE DEVICE IDENTIFIER NOT AVAILABLE. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem · 0
IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ ES SERVER CUSTOMER WAS PREPARING FOR A (B)(6) REGISTRATION CONVERSION FROM (B)(6) FOR ((B)(6) FACILITIES: (B)(6) HOSPITAL AND (B)(6)). THE CONVERSION WAS SCHEDULED TO BEGIN ON THE EARLY MORNING AT 4:00 AM PDT ON APRIL 25TH, WITH CONNECTIVITY TESTING EXPECTED BETWEEN 5:00 AM AND 8:00 AM PDT. DURING THIS WINDOW, (B)(6) AND FACILITY RESOURCES WOULD VALIDATE THAT (B)(6) WERE PROCESSING CORRECTLY POST-CONVERSION. HOWEVER, THERE WERE NO DELAYS OR ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 445262 | BD PYXIS¿ ES SERVER | AUTOMATED DISPENSING CABINET | BRY | CAREFUSION 303, INC. | 500001002501 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | GENERIC MEDSTATION ES. |