MAUDE Adverse Event Report: CAREFUSION 303, INC. BD Pyxis¿ ES Server; Automated Dispensing Cabinet

Model Number	500001002501
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	08/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when using the bd pyxis¿ es server multiple discontinued orders continued to appear under admitted and discharged patients.Patient profiles were not displayed correctly in pyxis, particularly for older patient records.The issue affected multiple patients across multiple pyxis devices, requiring users to use workarounds to access medications.The issue occurred after corrective actions for a corrupted file were performed, and orders were not processing correctly following the update.Ephi patient details were provided for investigation.The customer stated that this malfunction caused a delay in dispensing the medications to the patient.However, 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, 17-oct-2023 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 device's admit discharge transfer (adt) discharge messages could not be verified as received for the affected patients, and order discontinuation messages were not received from the source system for the affected orders.A technical support specialist (tss) reviewed the reported patient visibility and active order concerns, validated that carefusion coordination engine (cce) processing and interface services were functioning normally with no message backlog, analyzed database records and message traces, and confirmed that the expected admission, discharge, and order discontinuation messages were not received for the affected patients and orders.Further investigation identified that the product support engineer (pse) had been restored from the 08/19 backup as part of the disaster recovery effort, causing previously discontinued orders to reappear as active.Tss reviewed related cases, collaborated with internal resources, and determined that the issue was not caused by es or cce processing, but was associated with missing source-system messages and restored historical data.Existing interface team efforts were already in progress under related cases to assist with discontinuing the affected orders and coordinating resolution with the customer.The system functioned as intended after the technical support specialist troubleshot the device.

• Brand Name: BD Pyxis¿ ES Server
• Common Device Name: Automated Dispensing Cabinet
• Manufacturer (Section D): CAREFUSION 303, INC.; 3750 torrey view ct; san diego CA 92130
• Manufacturer (Section G): CareFusion 303, INC.; 10020 pacific mesa blvd; san diego CA 92121 -438
• Manufacturer Contact: brett wilko ; 3750 torrey view ct; san diego, CA 92130 ; +1(858)617-2000
• MDR Report Key: 50883632
• Report Number: 2016493-2026-66073
• Device Sequence Number: 16129293
• Product Code: BRY
• UDI-Device Identifier: 10885403518348
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 09/01/2026

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: 500001002501
• Device Catalogue Number: 1115-00
• 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: 08/29/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2023
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown