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	08/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when using the bd pyxis¿ medflex 1000 wrong drawer opened.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, 09-may-2023 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 issue was related to user error.A technical support specialist (tss) investigated the issue by remotely accessing the medbank and confirmed that drawer/zone 1 was configured as a non-button door, while zone 02 was configured as a matrix drawer.The tss explained the difference between these drawer types to the customer and verified that the medbank was opening the correct drawer and that the medication was assigned correctly in myqlink (mql).During the physical inventory review, all items in matrix drawer 02 matched the bin locations in mql except for position 02, which contained levothyroxine 25 mcg tablets.The tss assisted the customer in opening all matrix drawers and located the amoxicillin/potassium clavulanate 875 mg/125 mg tablets in bin 05-12, a bin with no medication assigned.The customer moved the medication to the correct location and verified a quantity of four tablets.Based on the findings, the issue was determined to be the result of a possible human or restocking error.The medication was relocated to the correct bin, resolving the issue.The system functioned as intended after the technical support specialist assessed 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: 50911151
• Report Number: 2016493-2026-66546
• Device Sequence Number: 20166131
• Product Code: BRY
• UDI-Device Identifier: 10885403512704
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: 05/09/2023
• 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