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

Model Number	500001004001
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when using the bd pyxis¿ pro medstation¿ main, refrigerator in the pyxis frequently displayed a "refrigerator fail" error.The issue occurred repeatedly and was suspected to be related to lock or door alignment problems.The customer stated that the malfunction occurred when a user tried to issue medication to the patient and caused a delay to patient care.However, there were no adverse events or injuries reported based on this event.
Additional Manufacturer Narrative
A review of the complaint history for (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 complaint history for (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 (b)(6) was performed from the date of manufacture, 10-jun-2026 and confirmed that this device was not previously returned for servicing and there were no production failures which correlates to the customer reported issue.A review of the device history record for (b)(6) was performed from the date of manufacture, 09-apr-2026 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 had slight hasp alignment issue.A field service engineer (fse) fixes the hasp plate alignment to resolve the issue.The system functioned as intended after the field service engineer repaired the device.

• Brand Name: BD Pyxis¿ Pro MedStation¿ Main
• 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: 50850746
• Report Number: 2016493-2026-64937
• Device Sequence Number: 15841110
• Product Code: BRY
• UDI-Device Identifier: 10885403521300
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/02/2026

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: 500001004001
• Device Catalogue Number: 1155-00
• 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: 08/25/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SN: 18438952
• Patient Sex: Unknown