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

Model Number	500004500500
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Application Program Problem (2880)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when using the bd pyxis¿ medbank mini the station was stuck on blue screen.The customer attempted to reboot the machine and unplugged and replugged the power cable; however, the issue persisted.However, 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-oct-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 station was stuck on blue screen.The field service engineer (fse) found the station displaying a blue screen with a windows startup error and determined that the system could not boot correctly.The fse reseated the hard drive and attempted multiple recovery procedures, including safe mode, last known good configuration, and automated repair; however, the station remained unbootable.The fse then attempted to obtain a replacement hard drive, but the required part was not immediately available, resulting in the repair being postponed pending part acquisition.After a replacement hard drive became available, the fse installed the new hard drive, restored the station to operational status, and verified that the application launched successfully.The fse then transferred the station to the technical support center (tsc) for database rebuild activities.The issue was resolved, and the station was returned to service.The system functioned as intended after the field service engineer repaired the device.

• Brand Name: BD Pyxis¿ MedBank Mini
• 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: 50911626
• Report Number: 2016493-2026-66577
• Device Sequence Number: 17491217
• Product Code: BRY
• UDI-Device Identifier: 10885403517181
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 09/03/2026

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: 500004500500
• Device Catalogue Number: 1147-00
• 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: 08/31/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2024
• 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