MAUDE Adverse Event Report: CAREFUSION 303, INC. BD PYXIS ANESTHESIA SYSTEM (PAS) 4000; AUTOMATED DISPENSING CABINET

Model Number	338
Medical Device Problem Codes	Computer Software Problem (1112); Unintended Application Program Shut Down (4032)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported that a pyxis anesthesia 4000 system experiences continuous shutdowns and reboots during use.The customer stated user was unable to log in to device.The length of the delay to patient care was not disclosed.The nature of the procedure was not disclosed.There was no reported patient or user harm.
Additional Manufacturer Narrative
Customer reported that a pyxis anesthesia 4000 system experiences continuous shutdowns and reboots during use.The customer stated user was unable to log in to device.The length of the delay to patient care was not disclosed.The nature of the procedure was not disclosed.There was no reported patient or user harm.This event is recorded in complaint number (b)(4).A technical support specialist remotely accessed the device, finding no evidence of a system error message.The technical support specialist performed a database clean and reinstated a clean database to mitigate the reported issue.Customer confirmed device was operational.
Additional Manufacturer Narrative
Corrections and or additional information has been added to the following sections: a1, d4, d5, d9, g1, h2, h6.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 11-aug-2020 to 11-aug-2022 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 system experienced continuous shutdown and reboots due to software issues.The technical support specialist dialed into the station and found no evidence of error message.He performed a database cleaning to mitigate the issue.The system functioned as intended after the technical support specialist assessed the device.
Event or Problem Description
Customer reported that a pyxis anesthesia 4000 system experiences continuous shutdowns and reboots during use.The customer stated user was unable to log in to device.The length of the delay to patient care was not disclosed.The nature of the procedure was not disclosed.There was no reported patient or user harm.

• Brand Name: BD PYXIS ANESTHESIA SYSTEM (PAS) 4000
• Common Device Name: AUTOMATED DISPENSING CABINET
• Manufacturer (Section D): CAREFUSION 303, INC.; 10020 pacific mesa blvd.; san diego CA 92130
• Manufacturer (Section G): CAREFUSION 303; 10020 pacific mesa blvd.; san diego CA 92121
• Manufacturer Contact: phillip emmert ; 10020 pacific mesa blvd.; san diego, CA 92130
• MDR Report Key: 15384834
• Report Number: 2016493-2022-99148
• Device Sequence Number: 12211714
• Product Code: BRY
• UDI-Device Identifier: 10885403477829
• UDI-Public: (01)10885403477829
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 338
• Device Catalogue Number: 338KMAT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2022
• Supplement Date Received by Manufacturer: 08/11/2022
• Initial Report FDA Received Date: 09/08/2022
• Supplement Report FDA Received Date: 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown