MAUDE Adverse Event Report: CAREFUSION 303, INC. BD Pyxis¿ MedStation¿ 4000 Integrated Main; Automated Dispensing Cabinet

Model Number	500001002002
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	07/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when using the bd pyxis¿ medstation¿ 4000 integrated main, the cubie not detected on bus.As per part investigation, it was determined that damage on two lines of the flat flex cable, in addition to exhibiting bends in the structure which led to thermal damage.There was no delay, no adverse events or injuries reported based on this event.
Additional Manufacturer Narrative
E1: initial reporter facility name - (b)(6) hospital.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, 29-nov-2017 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 cubies not detected on bus was confirmed by field service engineer (fse) and subsequently confirmed in the dchu inspection process.According to work order #(b)(4), the fse reported that the unit was inspected and intermittent failures were detected in station drawer one.After testing, the retractor band was replaced, connections were secured, and debris were removed.To verify the repair, the customer inventoried medications and confirmed satisfactory system performance.During dchu visual inspection: pn 353844-01: a visual inspection and a microscopic inspection (ncr: c15-3125) of the returned material were performed, which showed damage on two lines of the flat flex cable, in addition to exhibiting bends in the structure.During dchu testing: pn 353844-01: no functional tests were performed due to physical damage of the received part.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 cubies not detected on bus is attributed to the physical damage of the part pn 353844-01 which produces a miscommunication.

• 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 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: 50022059
• Report Number: 2016493-2026-48170
• Device Sequence Number: 13165748
• Product Code: BRY
• UDI-Device Identifier: 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): 07/21/2026

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: 000000000000000306
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/15/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2026
• Initial Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2017
• 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