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

Model Number	500001002000
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2025
Type of Reportable Event	Malfunction
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, 18-jan-2022 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 half height cubie drawer 2-1 was confirmed by fse and subsequently confirmed in the dchu inspection process.According to work order #(b)(4) the fse reported that half height cubie drawer 2-1 on the main was failing, cubie pockets with read/write error message.The fse reseated the row board cable and ribbon cable and replaced the retractor band.Finally, the fse ran a final test in the drawer in hardware test application.The report was closed.During dchu visual inspection: pn 353844-01: was observed a short between adjacent copper strands.During dchu testing: pn 353844-01: dchu testing was not required due to the thermal damage observed during the visual inspection.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 a drawer failure was due to a short between adjacent copper strands of the assy retractor dwr hh cubie (p/n 353844-01) which led to the observed thermal damage.
Event or Problem Description
It was reported that when using the bd pyxis¿ medstation¿ 4000, the half height cubie drawer 2-1 failed.As per part investigation, it was determined that there was thermal damage observed due to a short between adjacent copper strands of the assy retractor dwr hh cubie.There were no adverse events or injuries reported based on this event.

• Brand Name: BD PYXIS¿ MEDSTATION¿ 4000
• 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: 25146316
• Report Number: 2016493-2026-27843
• Device Sequence Number: 9323918
• Product Code: BRY
• UDI-Device Identifier: 10885403512629
• UDI-Public: (01)10885403512629
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/08/2026

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: 500001002000
• Device Catalogue Number: 303
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2026
• Initial Report FDA Received Date: 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2022
• 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