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

Model Number	500001004001
Medical Device Problem Codes	Mechanical Problem (1384); Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when using the bd pyxis¿ pro medstation main drawer 6 had failed, and the rail needed to be replaced.The customer attempted troubleshooting by rebooting the station and trying to recover the drawer; however, the problem persisted.The customer stated that they were unable to access the medication, and the user managed to get the medication from another pyxis station, which caused a delay to the patient care.There were no adverse events or injuries reported based on this event.
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, 23-dec-2025 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 main drawer 6 was failed.A field service engineer (fse) responded to a report that full height drawer 6 on the medstation pro was not opening properly and conducted an onsite inspection, observing inconsistent opening, limited extension, and frequent clicking noises indicating failure.The fse identified that the left and right slide rail tracks were misaligned and that the bearings on the slide rails were dry and lacking lubrication, causing stiffness.The fse corrected the alignment of the racks and replaced both slide rails, after which the drawer operated smoothly and reliably, confirming that the medstation pro and its full height drawer 6 were restored to proper working condition.The system functioned as intended after the field service engineer repaired the device.

• Brand Name: BD PYXIS¿ PRO MEDSTATION MAIN
• Common Device Name: AUTOMATED DISPENSING CABINET
• Manufacturer (Section D): CAREFUSION 303, INC.; 3750 torrey view ct; san diego CA 92130
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS S.A DE C.V.; parque sur, el realito; blvd. 2000; tijuana 22250 ; MX 22250
• Manufacturer Contact: brett wilko ; 3750 torrey view ct; san diego, CA 92130 ; 8586172000
• MDR Report Key: 25471307
• Report Number: 2016493-2026-36181
• Device Sequence Number: 16028893
• Product Code: BRY
• UDI-Device Identifier: 10885403521300
• UDI-Public: (01)10885403521300
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/19/2026

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: 500001004001
• Device Catalogue Number: 1155-00
• 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: 05/13/2026
• Initial Report FDA Received Date: 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/23/2025
• 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