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

Model Number	500001002500
Medical Device Problem Code	Labelling, Instructions for Use or Training Problem (1318)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when using the bd pyxis¿ medstation¿ es, one patient was not showing on pyxis.The customer stated that this malfunction occurred while dispensing the medication 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 complaints 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, 31-oct-2022 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 one patient information was not shown on the pyxis.The technical support specialist (tss) checked the server and confirmed that the patient had been inactive beyond the configured duration in the pyxis station.The customer was advised to extend the inactive patient duration and re-enable the patient record to restore visibility.The system functioned as intended after the technical support specialist resolved the issue.

• 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: 23534411
• Report Number: 2016493-2025-134034
• Device Sequence Number: 13308718
• Product Code: BRY
• UDI-Device Identifier: 10885403512667
• UDI-Public: (01)10885403512667
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 10/19/2025

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: 10/15/2025
• Initial Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2022
• 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