MAUDE Adverse Event Report: CAREFUSION 303, INC. BD PYXIS¿ MEDSTATION¿ 4000 INTEGRATED MAIN; AUTOMATED DISPENSING CABINET

Model Number	500001002002
Medical Device Problem Codes	Break (1069); Thermal Decomposition of Device (1071); Circuit Failure (1089)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E.1 initial reporter facility name: (b)(6).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 the date of manufacture, 11-may-2018 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 ¿medes - half height drawer off bus¿ was confirmed during field service engineer (fse) testing and subsequently confirmed in the dchu testing process.The device was initially evaluated by the field service engineer (fse) according to work order: (b)(4), the fse reported that replaced the pyxibus module controller and drawer controller boards and, upon booting up the station.The fse observed that none of the drawers were detected in diagnostics.The fse then manually removed all pockets from drawer 4.1 and cleaned debris from underneath them, followed by rebooting the station; however, the same issue persisted.All cables were reseated and inspected with no faults found.Finally, the fse replaced the retractor band, which resolved the issue.The fse replaced missing or damaged slide bumpers in drawers.During dchu visual inspection: p/n: 353844 01: was received with copper strands in contact with adjacent copper strands.P/n: 151622 01: the part showed no signs of physical damage, fluid ingress, loose or missing components.P/n: 151630 01: the part was received with a detached connector (j402).During dchu testing: p/n: 353844 01: the testing from dchu was not necessarily due to the thermal damage observed on copper strands during the visual inspection.P/n: 151622 01: passed the dmm and hta testing.P/n: 151630 01: due to physical damage found during the external inspection, no further testing was required.The device was in use for treatment purposes as intended per 21 cfr 820.198(d).Root cause: the root cause of the complaint of ¿medes half height drawer off bus¿ was due to crossed continuity between adjacent copper strands of the ¿assy retractor dwr hh cubie¿ (p/n: 353844-01) which led to the observed thermal damage and ultimately compromised the drawer's functionality.A faulty ¿pcba pmc v1.06/v0.09bl hh¿, p/n: 151630 01 due to a detached connector (j402), which prevents the proper functionality of the board.
Event or Problem Description
It was reported that when using the bd pyxis¿ medstation¿ 4000 integrated main drawer was failed.The fse found that drawer 4.1 was off the bus despite multiple reboots and cable reseating attempts.Only three indicator lights were illuminated on the back of the t board, and the top right indicator light was off.As per part investigation, it was determined that the half height drawer was off bus due to crossed continuity in the retractor assembly and a faulty pmc board with a detached connector (j402) led to the observed thermal damage.However, there were no delay to patient care and no adverse events or injuries reported based on this incident.

• Brand Name: BD PYXIS¿ MEDSTATION¿ 4000 INTEGRATED MAIN
• Common Device Name: AUTOMATED DISPENSING CABINET
• Manufacturer (Section D): CAREFUSION 303, INC.; 3750 torrey view ct; san diego CA 92130
• Manufacturer (Section G): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: brett wilko ; 3750 torrey view ct; san diego, CA 92130 ; 8586172000
• MDR Report Key: 25719858
• Report Number: 2016493-2026-43180
• Device Sequence Number: 5217636
• Product Code: BRY
• UDI-Device Identifier: 10885403512636
• UDI-Public: (01)10885403512636
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 07/06/2026

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: 500001002002
• Device Catalogue Number: 306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2026
• Initial Report FDA Received Date: 07/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2018
• 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
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown