BD PYXIS¿ ANESTHESIA STATION ES
Report
- Report Number
- 2016493-2025-115370
- Event Type
- Death
- Date Received
- September 18, 2025
- Date of Event
- August 22, 2025
- Report Date
- October 29, 2025
- Manufacturer
- CAREFUSION 303, INC.
- Product Code
- BRY
- UDI-DI
- 10885403533242
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VT, 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.
ADDITIONAL INFORMATION: SECTION H IMDRF ANNEX CODES. CORRECTION: SECTION D UNIQUE IDENTIFIER (UDI). 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, 22-SEP-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 FOUND THAT A MEDICATION RETRIEVAL ATTEMPT HAD BEEN MADE FOR A PATIENT. A TECHNICAL SUPPORT SPECIALIST (TSS) REVIEWED THE DATA SYNC AND MED APPLICATION LOGS FOR STATION M7OB2 AND FOUND NO ERRORS OR SYSTEM DOWNTIME DURING THE SPECIFIED TIMEFRAME. THE ALL-DEVICE EVENTS REPORT SHOWED NO TRANSACTIONS BETWEEN 4:00 AM AND 6:00 AM EST. NO SPECIFIC ERRORS WERE FOUND IN THE LOGS RELATED TO THE REPORTED INCIDENT. THE CUSTOMER REQUESTED ADDITIONAL EVENT VIEWER LOG DETAILS FOR STATION M7OB2, FOCUSING ON THE TIMEFRAME FROM 4:00 AM TO 8:00 AM EST, ESPECIALLY AROUND 6:55 AM EST. UPON FURTHER REVIEW, THE TSS IDENTIFIED A HARDWARE-RELATED ERROR IN DRAWER 2.1 WITH THE FAILURE CODE "FAILEDTOUNLOCK" ON STATION M7OB2 AROUND THAT TIME. HOWEVER, LATER LOG ENTRIES CONFIRMED THAT THE SYSTEM CONTINUED TO WORK NORMALLY AFTER THE ERROR. DRAWERS 1.1, 2.1 AND 2.2 WERE ACCESSED SUCCESSFULLY MULTIPLE TIMES. THE TSS REVIEWED THE EVENT VIEWER LOGS THOROUGHLY AND FOUND NO ANOMALIES DURING THE SPECIFIED TIMEFRAME FROM 4:00 AM TO 8:00 AM EST. THE TSS SHARED THE FINDINGS AND CLOSED THE CASE.
IT WAS REPORTED THAT A PATIENT WAS RUSHED TO THE BIRTHING CENTER OPERATING ROOM DUE TO POSTPARTUM HEMORRHAGE. THE BD PYXIS¿ ANESTHESIA SYSTEM ES (PAS) WAS USED BY THE ANESTHESIA PROVIDER THROUGHOUT THE PROCEDURE, ALTHOUGH THE SPECIFIC TYPE OF PROCEDURE WAS NOT DISCLOSED BY THE CUSTOMER. AT SOME POINT DURING THE CASE, THE PATIENT REQUIRED MULTIPLE DOSES OF CALCIUM CHLORIDE AND CALCIUM GLUCONATE INJECTIONS. THE REASON FOR ADMINISTERING THESE MEDICATIONS WAS NOT PROVIDED. THE SUPPLY OF BOTH CALCIUM CHLORIDE AND CALCIUM GLUCONATE IN THE PAS MACHINE WAS EVENTUALLY DEPLETED. THE ANESTHESIA PROVIDER ATTEMPTED TO RETRIEVE ADDITIONAL MEDICATION FROM THE PAS MACHINE IN THE ADJACENT ROOM BUT WAS REPORTEDLY UNABLE TO ACCESS IT BETWEEN 2:00 AM AND 7:00 AM. AS A RESULT, THEY HAD TO RUN DOWN ¿4 FLOORS¿ TO ANOTHER PYXIS STATION TO OBTAIN A FEW VIALS. THE CUSTOMER REVIEWED THE DEVICE LOGS, WHICH CONFIRMED THE PROVIDER¿S LOGIN ATTEMPTS. ULTIMATELY, THE MEDICATIONS WERE OBTAINED FROM PYXIS STATIONS ON A DIFFERENT FLOOR AND FROM THE CODE CART. UNFORTUNATELY, IT WAS REPORTED THAT THE PATIENT DIED. THE MANAGER OF PHARMACY OPERATIONS STATED THAT THE DEVICE WAS NOT CONSIDERED A CONTRIBUTING FACTOR IN THE PATIENT¿S OUTCOME. ALTHOUGH ADDITIONAL DETAILS WERE REQUESTED, THE CUSTOMER DECLINED TO PROVIDE.
IT WAS REPORTED THAT A PATIENT WAS RUSHED TO THE BIRTHING CENTER OPERATING ROOM DUE TO POSTPARTUM HEMORRHAGE. THE BD PYXIS¿ ANESTHESIA SYSTEM ES (PAS) WAS USED BY THE ANESTHESIA PROVIDER THROUGHOUT THE PROCEDURE, ALTHOUGH THE SPECIFIC TYPE OF PROCEDURE WAS NOT DISCLOSED BY THE CUSTOMER. AT SOME POINT DURING THE CASE, THE PATIENT REQUIRED MULTIPLE DOSES OF CALCIUM CHLORIDE AND CALCIUM GLUCONATE INJECTIONS. THE REASON FOR ADMINISTERING THESE MEDICATIONS WAS NOT PROVIDED. THE SUPPLY OF BOTH CALCIUM CHLORIDE AND CALCIUM GLUCONATE IN THE PAS MACHINE WAS EVENTUALLY DEPLETED. THE ANESTHESIA PROVIDER ATTEMPTED TO RETRIEVE ADDITIONAL MEDICATION FROM THE PAS MACHINE IN THE ADJACENT ROOM BUT WAS REPORTEDLY UNABLE TO ACCESS IT BETWEEN 2:00 AM AND 7:00 AM. AS A RESULT, THEY HAD TO RUN DOWN ¿4 FLOORS¿ TO ANOTHER PYXIS STATION TO OBTAIN A FEW VIALS. THE CUSTOMER REVIEWED THE DEVICE LOGS, WHICH CONFIRMED THE PROVIDER¿S LOGIN ATTEMPTS. ULTIMATELY, THE MEDICATIONS WERE OBTAINED FROM PYXIS STATIONS ON A DIFFERENT FLOOR AND FROM THE CODE CART. UNFORTUNATELY, IT WAS REPORTED THAT THE PATIENT DIED. THE MANAGER OF PHARMACY OPERATIONS STATED THAT THE DEVICE WAS NOT CONSIDERED A CONTRIBUTING FACTOR IN THE PATIENT¿S OUTCOME. ALTHOUGH ADDITIONAL DETAILS WERE REQUESTED, THE CUSTOMER DECLINED TO PROVIDE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2840492 | BD PYXIS¿ ANESTHESIA STATION ES | AUTOMATED DISPENSING CABINET | BRY | CAREFUSION 303, INC. | 500400001500 | 10885403533242 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Death |