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

Model Number	500001002506
Medical Device Problem Code	Unintended Application Program Shut Down (4032)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when using the bd pyxis¿ medstation¿ es tower, the station repeatedly reverted to a frozen blue carefusion screen.The customer stated that there was a delay in 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-oct-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 recurring issue on the station was caused by a combination of bio id (biometric identifier) authentication failures associated with an older lumidigm hardware/software version, an incorrect medication application auto launch configuration, and excessive database bloat that contributed to degraded station performance and intermittent startup issues following overnight reboot.A technical support specialist (tss) applied the appropriate lumidigm shim update, corrected and validated the med app auto launch configuration, and performed database maintenance and a full sync to reduce database size and improve performance.Post repair testing confirmed successful bio id authentication, proper med app launch after reboot, improved system responsiveness, and verified that all reported issues were resolved and approved case closure.The system functioned as intended after the technical support specialist troubleshot the device.

• Brand Name: BD Pyxis¿ MedStation¿ ES Tower
• 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 ; +1(858)617-2000
• MDR Report Key: 50867870
• Report Number: 2016493-2026-65566
• Device Sequence Number: 16131337
• Product Code: BRY
• UDI-Device Identifier: 10885403512674
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 08/31/2026

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: 500001002506
• Device Catalogue Number: 352
• 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: 08/27/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2025
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown