BD PYXIS¿ ANESTHESIA STATION ES
Report
- Report Number
- 2016493-2024-00453
- Event Type
- Injury
- Date Received
- July 3, 2024
- Date of Event
- June 5, 2024
- Report Date
- March 17, 2025
- Manufacturer
- CAREFUSION 303, INC.
- Product Code
- BRY
- UDI-DI
- 10885403477836
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- PHARMACIST
- Health Professional
- Yes
Narratives
INVESTIGATION PENDING; A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION PROCESS HAS BEEN COMPLETED.
"THIS SUPPLEMENTAL REGULATORY REPORT IS BEING SUBMITTED DUE TO A RETROSPECTIVE REVIEW CONDUCTED THROUGH CAPA 10308384. THE LATE SUBMISSION OF THIS SUPPLEMENTAL REPORT IS DUE TO THE THOROUGH AND DETAILED NATURE OF THE RETROSPECTIVE REVIEW PROCESS. THIS PROCESS WAS ESSENTIAL TO ACCURATELY CAPTURE ALL RELEVANT DATA AND ENSURE THE INTEGRITY OF OUR REPORTING. WE HAVE INCLUDED THE CAPA REFERENCE FOR THE RETROSPECTIVE REVIEW IN THE ADDITIONAL MANUFACTURER NARRATIVE SECTION OF THE FDA FORM 3500A, AS RECOMMENDED. CORRECTIONS AND OR ADDITIONAL INFORMATION HAS BEEN ADDED TO THE FOLLOWING SECTIONS: D1, D5, H6, H11. A REVIEW OF THE COMPLAINT HISTORY FOR SN (B)(6) WAS PERFORMED IN SALESFORCE WHICH DID NOT LOCATE SIMILAR COMPLAINTS WITH THE SAME FAILURE MODE FOR THIS SERIAL NUMBER. A REVIEW OF THE DEVICE HISTORY RECORD FOR SN (B)(6) WAS PERFORMED FROM (B)(6)2022 TO (B)(6)2024 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 STATION WAS UNEXPECTEDLY TAKEN DOWN BY A TECHNICAL SUPPORT SPECIALIST. THE TECHNICAL SUPPORT SPECIALIST PERFORMED REMOTE WORK OUTSIDE THE AGREED TIMEFRAME, WITHOUT CONFIRMATION THAT THE STATIONS WERE NOT IN USE. NO PRODUCT MALFUNCTION CAUSED THIS EVENT. THE SYSTEM FUNCTIONED AS INTENDED AFTER THE TECHNICAL SUPPORT SPECIALIST ASSESSED THE DEVICE.
SECTION H6 - UPDATED CODES FOR INVESTIGATION FINDINGS AND CONCLUSIONS TO REFLECT THE RESOLUTION OF THE COMPLAINT INVESTIGATION. SECTION H11 UPDATE - UPON INVESTIGATION OF THE ACTUAL DEVICE USED IN THIS INCIDENT IT WAS DETERMINED THAT THE STATION WAS UNEXPECTEDLY BROUGHT DOWN BY A TECHNICAL SUPPORT SPECIALIST. A REMOTE WORK WAS PERFORMED BY THE TECHNICAL SUPPORT SPECIALIST ON A DIFFERENT TIME FRAME WHICH WAS NOT PROVIDED BY CUSTOMER AND THERE WAS NO PRODUCT MALFUNCTION CAUSED THIS EVENT. THE SYSTEM FUNCTIONED AS INTENDED.
IT WAS REPORTED BY THE CUSTOMER THAT A PYXIS ANESTHESIA ES SYSTEM WAS UNEXPECTEDLY BROUGHT DOWN BY A TECHNICAL SUPPORT SPECIALIST DURING A PROCEDURE. CUSTOMER STATED THAT THEY WERE UNABLE TO REMOVE THE REQUIRED MEDICATIONS DUE THE REMOTE WORK PERFORMED ON A DIFFERENT TIME FRAME WHICH WAS NOT PROVIDED BY CUSTOMER, RESULTED IN PATIENT HARM. THE MANUFACTURER REACHED OUT TO THE CUSTOMER FOR ADDITIONAL INFORMATION REGARDING THE EVENT, BUT NO OTHER INFORMATION WAS RELEASED.
IT WAS REPORTED BY THE CUSTOMER THAT A PYXIS ANESTHESIA ES SYSTEM WAS UNEXPECTEDLY BROUGHT DOWN BY A TECHNICAL SUPPORT SPECIALIST DURING A PROCEDURE. CUSTOMER STATED THAT THEY WERE UNABLE TO REMOVE THE REQUIRED MEDICATIONS DUE THE REMOTE WORK PERFORMED ON A DIFFERENT TIME FRAME WHICH WAS NOT PROVIDED BY CUSTOMER, RESULTED IN PATIENT HARM. THE MANUFACTURER REACHED OUT TO THE CUSTOMER FOR ADDITIONAL INFORMATION REGARDING THE EVENT, BUT NO OTHER INFORMATION WAS RELEASED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 551276 | BD PYXIS¿ ANESTHESIA STATION ES | AUTOMATED DISPENSING CABINET | BRY | CAREFUSION 303, INC. | 327 | 10885403477836 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |