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

Model Number	500001002502
Medical Device Problem Codes	Circuit Failure (1089); Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when using the bd pyxis¿ medstation¿ es auxiliary, the drawer failed.As per part investigation, it was determined that the fluid ingress condition of the part module controller.There were no adverse events or injuries reported based on this event.
Additional Manufacturer Narrative
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, 11-dec-2020 and confirmed that this device was not previously returned for servicing and there were no production failures which correlates to the customer reported issue.Part analysis: the reported condition of station reported as dead along with a half-height drawer was confirmed by field service engineer (fse) and subsequently confirmed in the dchu testing and inspection process.According to work order #(b)(4), bd fse reported that half-height drawer 2.1 caused the station not to power on.Bd fse replaced the drawers pcba (pyxibus module controller and drawer controller board).The device was then reconfigured and tested.The device operated as intended, exhibiting no further issues.During dchu visual inspection: pn (b)(4) - sn (b)(6): no signs of physical damage, missing components, electrical failure, or any anomalies were found during inspection.Pn (b)(4) - sn (b)(6): no signs of physical damage, missing components, electrical failure, or any anomalies were found during inspection.Pn (b)(4)- sn (b)(6): upon inspection, no physical damage was found.However, the front of the pcba exhibited signs of fluid ingress.During dchu testing: pn (b)(4) - sn (b)(6): evaluation found a shorted diode d501/mosfet q501.Pn (b)(4) - sn (b)(6): the returned pcba was fully tested using a digital multimeter and the hta and operated as intended.Pn (b)(4) - sn (b)(6): as the issue was visually confirmed within external inspection, the pcba was considered faulty.In accordance with the pap, no further testing was performed.The device was in use for treatment purposes as intended per 21 cfr 820.198(d).Root cause: the root cause of the reported failure is attributed to the fluid ingress condition of the part pn (b)(4) which produces a short/miscommunication.Additionally, a short circuit was found affecting diode d501 and mosfet q501 on the pcba dwr cntlr v1.10/v1 pn (b)(4).These combined faults contributed directly to the malfunction reported by the customer.

• Brand Name: BD Pyxis¿ MedStation¿ ES Auxiliary
• 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: 50942961
• Report Number: 2016493-2026-67473
• Device Sequence Number: 9623897
• Product Code: BRY
• UDI-Device Identifier: 10885403533235
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/24/2026

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: 500001002502
• Device Catalogue Number: 324
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/11/2026
• 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: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2020
• 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