BD PYXIS¿ MEDSTATION¿ ES AUXILIARY
Report
- Report Number
- 2016493-2025-96358
- Event Type
- Malfunction
- Date Received
- July 14, 2025
- Date of Event
- June 19, 2025
- Report Date
- August 11, 2025
- Manufacturer
- CAREFUSION 303, INC.
- Product Code
- BRY
- UDI-DI
- 10885403512681
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
CORRECTION: SECTION H IMDRF ANNEX G.
THE FOLLOWING FIELD HAD BEEN UPDATED WITH ADDITIONAL INFORMATION: H6. 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, 04-OCT-2021 AND CONFIRMED THAT THIS DEVICE WAS NOT PREVIOUSLY RETURNED FOR SERVICING AND THERE WERE NO PRODUCTION FAILURES WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT, IT WAS DETERMINED THAT THE DRAWER HAD FAILED. A FIELD SERVICE ENGINEER (FSE) FOUND THAT DRAWERS 1.1 AND 1.2 WERE NOT DETECTED ON THE BUS. THE STATION WAS POWERED DOWN, AND THE DRAWER WAS DISASSEMBLED FOLLOWING THE INSTRUCTIONS OUTLINED IN FSG SECTION 3.11.3. WHILE THE DRAWER WAS DISASSEMBLED, THE FSE RESEATED THE RETRACTOR BAND CABLE AT BOTH THE DRAWER AND THE MODULE CONTROLLER. THE ROW BOARD CABLE WAS ALSO RESEATED AT THE DRAWER CONTROLLER AND THE INDIVIDUAL ROW BOARDS. AFTER REASSEMBLING THE DRAWER, THE DEVICE WAS POWERED BACK ON, AND DRAWER FUNCTIONALITY WAS VERIFIED IN DIAGNOSTICS. ALL DRAWERS WERE CONFIRMED TO BE FUNCTIONAL. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE FIELD SERVICE ENGINEER REPAIRED THE DEVICE.
IT WAS REPORTED WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES AUXILIARY, ALL DRAWERS WERE NOT DETECTED ON THE COMMUNICATION BUS. THE CUSTOMER REPORTED THAT THE MALFUNCTION RESULTED DELAY IN DISPENSING OF THE MEDICATION TO THE PATIENT. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS INCIDENT.
IT WAS REPORTED WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES AUXILIARY, ALL DRAWERS WERE NOT DETECTED ON THE COMMUNICATION BUS. THE CUSTOMER REPORTED THAT THE MALFUNCTION RESULTED DELAY IN DISPENSING OF THE MEDICATION TO THE PATIENT. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS INCIDENT.
IT WAS REPORTED WHEN USING THE BD PYXIS¿ MEDSTATION¿ ES AUXILIARY, ALL DRAWERS WERE NOT DETECTED ON THE COMMUNICATION BUS. THE CUSTOMER REPORTED THAT THE MALFUNCTION RESULTED DELAY IN DISPENSING OF THE MEDICATION 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 |
|---|---|---|---|---|---|---|---|
| 793537 | BD PYXIS¿ MEDSTATION¿ ES AUXILIARY | AUTOMATED DISPENSING CABINET | BRY | CAREFUSION 303, INC. | 500001002502 | 10885403512681 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |