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

Model Number	500004500001
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	08/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when using the bd pyxis¿ medbank tower aux, an empty cubie opened during an attempt to dispense divalproex dr 250 mg tablet.Although the system indicated that one tablet remained in the cubie, the compartment was found to be empty.A cycle count was performed on the affected cubie, and the on-hand quantity was adjusted to zero.After the count correction, the dispense was retried and the station successfully opened an alternate cubie containing the medication.The customer reported that a malfunction took place when the user tried to dispense medication to the patient.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, 26-may-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 the actual device used in this incident, it was determined that the device's experienced an empty cubie opening unexpectedly during access.A technical support specialist (tss) investigated a dispensing discrepancy where the expected medication cubie opened empty despite the system indicating available inventory, performed a cycle count and adjusted the on-hand quantity to zero, after which the dispense was retried and the cabinet correctly opened the alternate cubie containing the medication to resolve the issue.The system functioned as intended after the technical support specialist troubleshot 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 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: 50911653
• Report Number: 2016493-2026-66571
• Device Sequence Number: 17580780
• Product Code: BRY
• UDI-Device Identifier: 10885403512575
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 09/18/2026

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: 169-22
• 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: 05/26/2022
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown