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

Model Number	500004502000
Medical Device Problem Code	Installation-Related Problem (2965)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when using the bd pyxis¿ medflex 1000, validation code was not working when user tried to issue the medication (tramadol) for a patient.The customer stated that this malfunction occurred while dispensing the medication.There were no 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, 12-apr-2017 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 validation code was not working.A technical support specialist (tss) remotely accessed the system via logmein and reviewed the transaction with the client.During troubleshooting, it was determined that the client was attempting to use the word "override" instead of entering the required validation code.The client stated that pharmacy had advised her to use "override," but the medication could not be issued using that method.Tss had the client restart the transaction and recreate the issue.Upon review, it was confirmed that the medication was already listed on the patient's profile; therefore, an override was not required.It was also determined that an incorrect validation code had been provided.Pharmacist guided the client to the correct validation code, and after entering the correct code, the client was able to successfully issue the medication.The system functioned as intended after the technical support specialist investigated the device.

• 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): 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: 50837661
• Report Number: 2016493-2026-64729
• Device Sequence Number: 18631268
• Product Code: BRY
• UDI-Device Identifier: 10885403512704
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 08/26/2026

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: 08/24/2026
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2017
• 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