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

Model Number	500001002500
Medical Device Problem Codes	Break (1069); Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2025
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, 04-oct-2023 and confirmed that this device was not previously returned for servicing and there were no production failures which correlate to the customer reported issue.Upon investigation of the actual device used in this incident, it was determined that the system had a drawer failure.The field service engineer discovered that the unit had a drawer issue that seemed to be linked to a connection problem with the drawer controller.However, it was later observed that drawer two had a significant sticking problem, accompanied by a grinding noise.A field service engineer identified that a portion of the rail had become dislodged where the bearing carrier was located.It was moving back and forth within the slide, which caused the drawer to stick severely at times.The field service engineer managed to remove the fragment before it could interfere with another component and create a more serious issue.The customer consolidates some of the other drawers and pockets that were not completely full, as they needed to use the damaged drawer temporarily.The fse replaced the drawer, and the unit was reconfigured, and all medication is now in a functional working position.A general inspection was conducted on the unit, during which all-in-one was cleaned, and the functionality of the barcode scanner was verified.Additionally, it was confirmed that all cables were in good working order with no damage.Debris that had accumulated around the unit was removed, including several random ball bearings that had fallen out of a drawer.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¿ es drawer 2.2 rails were broken.The customer stated that this malfunction occurred while dispensing the medication and caused a delay to the patient care.There were no adverse events or injuries reported based on this event.

• Brand Name: BD PYXIS¿ MEDSTATION¿ ES
• Common Device Name: AUTOMATED DISPENSING CABINET
• Manufacturer (Section D): CAREFUSION 303, INC.; 10020 pacific mesa blvd.; 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 ; 10020 pacific mesa blvd.; san diego, CA 92130
• MDR Report Key: 23541359
• Report Number: 2016493-2025-134741
• Device Sequence Number: 13164146
• Product Code: BRY
• UDI-Device Identifier: 10885403512667
• UDI-Public: (01)10885403512667
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/21/2025

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: 500001002500
• Device Catalogue Number: 323
• 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: 10/16/2025
• Initial Report FDA Received Date: 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2023
• 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