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

Model Number	500001002502
Medical Device Problem Code	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 drawer 5 was not detected on bus.As per part investigation, it was determined that the complaint was attributed to visual anomalies indicative of fluid ingress detected on the board.However, there were no delays or 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-sep-2019 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 aux drw 5 device not detected on bus was confirmed by fse and subsequently confirmed in the dchu testing and inspection process.According to work order#: (b)(4) the field service engineer (fse) reported auxiliar drawer 5 not detected.The fse replaced the drawer board and controller board.The operation was verified via inventory application without any issues.During dchu visual inspection: part number: 151622-01: the part was received with no signs of physical damage, missing components, loose components or fluid ingress.Part number 151903-01: the part was received with visual anomalies.During dchu testing: part number: 151622-01: the board was placed on an esd protected surface to analyze it using a dchu lab multimeter.The components of the board were analyzed (diodes, resistance, fuses), no anomalies were found.The board was installed in a dchu test device to perform a hta test.The test showed that the board is functioning as intended.Part number: 151903-01: no testing was necessary due to the observed visual anomalies on the board during visual inspection.The device was in use for treatment purposes as intended per 21 cfr 820.198(d).Root cause: part number: 151622-01: not determined, a complete inspection and functional testing were performed, no faults or irregularities were observed during the evaluation process.Part number: 151903-01: the root cause to the reported failure aux drw 5 device not detected on bus is attributed to the visual anomalies detected on the board, additional functional testing was performed on the drawer controller board, no faults or irregularities were observed during the evaluation process.

• 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: 50944382
• Report Number: 2016493-2026-67546
• Device Sequence Number: 10451935
• Product Code: BRY
• UDI-Device Identifier: 10885403533235
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: 04/06/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2019
• 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