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

Model Number	500001002502
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	09/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when using the bd pyxis¿ medstation¿ es auxiliary, a cached credential issue occurred.Following a major technology outage, users at ehsc were unable to log in to the pyxis cabinets after the ethernet connection was disconnected.The issue prevented access to the cabinets and ultimately required staff to open the back of the units to manually access cubies.The customer reported that other sites within the region were able to log in without issue, indicating the problem was isolated to the affected location.There were no delay or 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, 03-jul-2024 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 system had cached credential issue and user was unable to log into the pyxis cabinets after unplugging the ethernet.A technical support specialist (tss) reviewed the security settings on the es server and found that both enable disconnected mode authentication using biometric identifier and enable disconnected mode authentication using encrypted password were unchecked.Advised that these settings should be enabled to allow users to authenticate during network outages.Once enabled, stations would fall back to using cached credentials stored in the local station database when connectivity to the server is unavailable.Noted that this functionality would only apply to existing users whose credentials had previously been cached on the station.The system functioned as intended after the technical support specialist troubleshot the device.

• Brand Name: BD Pyxis¿ MedStation¿ ES Auxiliary
• 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: 50942539
• Report Number: 2016493-2026-67406
• Device Sequence Number: 9498751
• Product Code: BRY
• UDI-Device Identifier: 10885403533235
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other,Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

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: 500001002502
• Device Catalogue Number: 324
• 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: 09/03/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2024
• 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