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

Model Number	500001004001
Medical Device Problem Codes	Application Program Problem (2880); Unintended Application Program Shut Down (4032)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that when using the bd pyxis¿ medstation¿ es, when the user performed a soft shutdown of the device, the device sometimes rebooted automatically while running on battery backup power.However, there were no delays, adverse events or injuries reported based on this event.
Additional Manufacturer Narrative
Additional information: section b describe event or problem, section d medical device brand name & section h imdrf annex codes 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, 05-nov-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, a technical support specialist (tss) conducted testing on station across three shutdown scenarios.In the first scenario, a bd user logged in, navigated to shut down under station configuration utility, waited for the shutdown to complete, and then flipped off the power switch, the station shut down normally and remained powered off.In the second scenario, after initiating shutdown from station configuration utility, the power switch was turned off while the medapplication was still running, the station again shut down normally and remained powered off.In the third scenario, after initiating shutdown from station configuration utility, the power switch was turned off while the system was at the windows desktop, the station also shut down normally and remained powered off.Further the tss confirmed that the reported issue could not be replicated, and no further investigation was required.The system functioned as intended when the technical support specialist assessed the device.
Event or Problem Description
It was reported that when using the bd pyxis¿ pro medstation¿ main, when the user performed a soft shutdown of the device, the device sometimes rebooted automatically while running on battery backup power.However, there were no delays, adverse events or injuries reported based on this event.

• Brand Name: BD PYXIS¿ PRO MEDSTATION¿ MAIN
• 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: 24751144
• Report Number: 2016493-2026-18048
• Device Sequence Number: 13333441
• Product Code: BRY
• UDI-Device Identifier: 10885403521300
• UDI-Public: (01)10885403521300
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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,Followup
• Report Date (Section B): 04/17/2026

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: 03/05/2026
• Supplement Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 04/01/2026
• Supplement Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2025
• 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