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

Model Number	500004500501
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2026
Type of Reportable Event	Malfunction
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, 16-apr-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, it was determined that the cabinet was offline.A technical support specialist (tss) advised the user to contact the don to proceed with an override as appropriate and or reach out to pharmacy for guidance on the required procedure.The tss checked connections, and the machine was back online and synchronizing properly with myqlink.The system functioned as intended after the technical support specialist verified the device.
Event or Problem Description
It was reported that when using the bd pyxis¿ medbank mini aux, cabinet was offline and not synchronizing with myqlink.The customer attempted to issue a narcotic that requires an rxverify code.The customer stated that this malfunction occurred while dispensing the medication.There were no adverse events or injuries reported based on this event.

• Brand Name: BD PYXIS¿ MEDBANK MINI AUX
• 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 ; 8586172000
• MDR Report Key: 25135906
• Report Number: 2016493-2026-27767
• Device Sequence Number: 9480345
• Product Code: BRY
• UDI-Device Identifier: 10885403517198
• UDI-Public: (01)10885403517198
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 04/30/2026

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: 500004500501
• Device Catalogue Number: 1148-00
• 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: 04/13/2026
• Initial Report FDA Received Date: 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2025
• 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