MAUDE Adverse Event Report: CAREFUSION 303, INC. BD Pyxis¿ Medflex 1000; Automated Dispensing Cabinet

Model Number	500004502000
Medical Device Problem Code	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¿ medflex 1000, multiple discrepancies were identified involving lorazepam 0.5 mg tablets and oxycodone 5 mg tablets.The customer reported recurring countback errors where inventory counts unexpectedly increased during medication transactions.A c35 report was reviewed and confirmed multiple discrepancies for both medications.The customer requested investigation to determine whether the issue was related to user processing/counting errors or a potential system-related issue 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, 11-aug-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 facility had experienced multiple countback errors while issuing two particular medications.A technical support specialist (tss) reviewed the issue and determined that it was caused by user error.The tss found that the profiled medication was set to dispense a quantity of five, while only a quantity of one was required.The tss determined that the issue quantity had not been adjusted before dispensing, which resulted in the positive discrepancy.The system functioned as intended after the technical support specialist inspected the issue.

• Brand Name: BD Pyxis¿ Medflex 1000
• 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: 50911145
• Report Number: 2016493-2026-66545
• Device Sequence Number: 17475417
• Product Code: BRY
• UDI-Device Identifier: 10885403512704
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 09/02/2026

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: 500004502000
• Device Catalogue Number: 1139-00
• 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: 08/11/2026
• 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
• Patient Sex: Unknown