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

Model Number	500001002002
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).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, 15-dec-2016 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, it was determined that the station was not powered on.A field service engineer (fse) found several tower doors were not detected on the bus.Even though nursing couldnt find the keys at first, the fse was still able to test the station and perform a hardware recovery.After powering off the station, fse reseated all cables on the aux tower, and console, as one connection was not fully seated.Once everything was secured, the station was powered back on, and the hardware test passed successfully.Nursing recovered the doors with a witness, and all doors and latches were tested and confirmed to be working properly.The system functioned as intended after the field service engineer repaired the device.
Event or Problem Description
It was reported that when using the bd pyxis¿ medstation¿ 4000, the entire tower had been failing and required maintenance.The customer stated that this malfunction occurred while dispensing the medication which caused a delay to the patient care as they unable to get the medication.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.; 10020 pacific mesa blvd.; san diego CA 92130
• Manufacturer (Section G): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: brett wilko ; 10020 pacific mesa blvd.; san diego, CA 92130
• MDR Report Key: 24566870
• Report Number: 2016493-2026-12676
• Device Sequence Number: 9561694
• Product Code: BRY
• UDI-Device Identifier: 10885403512650
• UDI-Public: (01)10885403512650
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 02/20/2026

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: 314
• 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: 02/17/2026
• Initial Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2016
• 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