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

Model Number	500001002506
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when using the bd pyxis¿ medstation¿ es tower, the biometric identifier failed.As per part investigation, it was determined that the fluid ingress observed during visual inspection.There were no adverse events or injuries reported based on this event.
Additional Manufacturer Narrative
A review of the complaint history for (b)(6) was performed in salesforce which did not locate a similar com laint 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 05-oct-2021, was conducted.The review confirmed that no manufacturing nonconformances or production-related failures were identified that correlate with the customer-re orted issue.The reported condition of "bj-3swt-perfn bio-id pushed through, please service." was confirmed by fse, and subsequently validated in the dchi_j testing process.According to work order (b)(4): the field service engineer (fse) reported that the bio-id face plate was broken at the screw and then replaced it.The customer logged in and tested the bio-id multiple times, and the station was working as designed.During dchij visual inspection: pn 355343-11: the face plate was received with one screw insert damaged.Pn 135225-01: the sensor received with signs of fluid ingress.During dchu testing: pn 355343-11: due to the physical damage observed, functional testing was not necessary.Pn 135225-01: functional testing was not necessary due to the fluid ingress observed during visual inspection.The device was in use for treatment purposes as intended per 21 cfr 820.198(d).Root cause: the root cause to the reported failure "bj-3swt-perfn bio-id pushed through, please service." is attributed to the physical damage of the part pn 355343-11, which compromised the structural integrity of the component and resulting in the reported failure.Additionally, a "ready sensor (b)(6)" showed fluid ingress, however, this issue is considered as incidental from what customer reported.

• Brand Name: BD Pyxis¿ MedStation¿ ES Tower
• 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: 50893200
• Report Number: 2016493-2026-66122
• Device Sequence Number: 20333810
• Product Code: BRY
• UDI-Device Identifier: 10885403512674
• UDI-Public: (01)10885403512674
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

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: 500001002506
• Device Catalogue Number: 352
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/29/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2021
• 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