MAUDE Adverse Event Report: CAREFUSION 303, INC. BD Pyxis¿ Anesthesia Station ES; Automated Dispensing Cabinet

Model Number	500400001500
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when using the bd pyxis¿ anesthesia station es, the drawer failed to recover.As per part investigation, it was determined that fluid ingress in the connector area of p/n 133456-03 assy, ctrl unit, 1x1, ul, which produced a miscommunication.There were no adverse events or injuries reported based on this event.
Additional Manufacturer Narrative
A review of the complaint history for s/n (b)(6) was performed in salesforce which did not locate a similar complaint with the same failure mode for this serial number.A review of the device history record (dhr) for serial number (b)(6), covering the manufacturing period beginning on 22oct2021, was conducted.The review confirmed that no manufacturing nonconformances or production-related failures were identified that correlate with the customer-reported issue.The reported condition of failed hardware/drawer was confirmed by fse and subsequently confirmed in the dchu inspection process.According to work order # 01864164 the system was examined in hta, mini drawer 1.13 was found to fail when opening, the mini engine was replaced, and the service was restored.During dchu visual inspection: p/n 133456-03: the component was received with evidence of fluid ingress during dchu testing: p/n 133456-03: due to the damage found during the visual inspection on the component, no additional tests were performed.The device was in use for treatment purposes as intended per 21 cfr 820.198(d).Root cause: after investigation, it was determined that the root cause of the reported failed hardware/drawer was attributed to fluid ingress in the connector area of p/n 133456-03 assy, ctrl unit, 1x1, ul, which produced a miscommunication which compromised the drawer functionality.

• Brand Name: BD Pyxis¿ Anesthesia Station ES
• Common Device Name: Automated Dispensing Cabinet
• Manufacturer (Section D): CAREFUSION 303, INC.; 3750 torrey view ct; san diego CA 92130
• Manufacturer (Section G): CareFusion 303, INC.; 10020 pacific mesa blvd; san diego CA 92121 -438
• Manufacturer Contact: brett wilko ; 3750 torrey view ct; san diego, CA 92130 ; +1(858)617-2000
• MDR Report Key: 50942745
• Report Number: 2016493-2026-67464
• Device Sequence Number: 9534537
• Product Code: BRY
• UDI-Device Identifier: 10885403533242
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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: Other
• Device Model Number: 500400001500
• Device Catalogue Number: 327
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/28/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2021
• 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