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

Model Number	500001002002
Medical Device Problem Code	Application Program Problem (2880)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2026
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, 10-feb-2009 and confirmed that this device was not previously returned for servicing and there were no production failures which correlates to the customer reported issue.Upon investigation of the actual device used in this incident, a field service engineer (fse) tested the drawer in hardware test application (hta) confirmed with the customer that the issue was resolved by recovering the drawer and no further investigation was required.The system functioned as intended after the issue was resolved.
Event or Problem Description
It was reported that when using the bd pyxis¿ medstation¿ 4000 integrated main failed hardware message was displayed.The customer attempted to reboot the device and recover the failed drawer; however, it continued to show required maintenance.The customer also attempted to shut down the station by unplugging the power cord, then powered it back on and attempted to recover the drawer again, but the issue persisted.The customer stated that this malfunction occurred while dispensing the medication and they were unable to access the medication, which caused a delay to the patient care.There were no adverse events or injuries reported based on this event.

• 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: 25499790
• Report Number: 2016493-2026-36946
• Device Sequence Number: 16082141
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/21/2026

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: 306
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2026
• Initial Report FDA Received Date: 06/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2009
• 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