MAUDE Adverse Event Report: CAREFUSION 303, INC. BD PYXIS¿ MEDBANK TOWER AUX; AUTOMATED DISPENSING CABINET

Model Number	500004500001
Medical Device Problem Code	Application Program Problem (2880)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when using the bd pyxis¿ medbank tower aux, the system had a failed all-in-one (aio) unit where the screen was flickering.The lower half of the display showed intermittent horizontal green and pink lines, making it difficult to view the interface.After logging into the cubex application, the buttons were not visible due to the display issue.If the device screen becomes unresponsive, the application might be frozen.If this issue recurs, delays in dispensing medications especially critical drugs might cause or contribute to an adverse event.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-nov-2022 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 this incident, a technical support specialist (tss) guided the customer through troubleshooting steps, including powering the aio off and on using the power button; however, the customer reported that flickering lines were still present, though nearly transparent.The tss then guided the customer to restart the aio within the cubex application, but the issue persisted, with the lower half of the screen intermittently displaying horizontal green and pink lines.The customer again power-cycled the aio, which temporarily resolved the touchscreen issue.A field service engineer (fse) later worked with medbank support and based on the customer¿s confirmation that the flickering had disappeared and not returned, it was suggested to close the ticket.The system functioned as intended after the technical support specialist and field service engineer assisted and investigated with the issues the device.

• Brand Name: BD PYXIS¿ MEDBANK TOWER AUX
• Common Device Name: AUTOMATED DISPENSING CABINET
• Manufacturer (Section D): CAREFUSION 303, INC.; 3750 torrey view ct; san diego CA 92130
• Manufacturer (Section G): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: brett wilko ; 3750 torrey view ct; san diego, CA 92130 ; 8586172000
• MDR Report Key: 25733942
• Report Number: 2016493-2026-43592
• Device Sequence Number: 16073214
• Product Code: BRY
• UDI-Device Identifier: 10885403512575
• UDI-Public: (01)10885403512575
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Report Date (Section B): 06/12/2026

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: 500004500001
• Device Catalogue Number: 169-12
• 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: 06/10/2026
• Initial Report FDA Received Date: 07/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/03/2022
• 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