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	08/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when using the bd pyxis¿ medflex 1000 user was unable to issue medication because the right-hand pane was not populating with information needed to complete the transaction.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 (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, 07-feb-2024 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 user was unable to issue medication.A technical support specialist (tss) remotely connected to the workstation and reproduced the reported issue with the customer.Investigation found that the lorazepam order was in requested rx verify status with a medication quantity of 0, preventing issuance.The customer was advised that the quantity must be greater than 0 and the order must be approved through rx verify before the medication can be issued.The customer was instructed to contact the pharmacy to update and approve the order.The customer also reported a similar issue involving an antibiotic medication.Further investigation revealed that the drawer zones were not properly configured, with only zone 6 populated.The drawer zones were repopulated, restoring functionality, and the customer successfully issued the medication.During the call, the customer was advised that the lorazepam order had been rejected by the pharmacy.The customer was advised to follow up with the pharmacy regarding the rejected order and customer acknowledged the recommendation.No downtime and no further problem was reported.The system functioned as intended after the technical support specialist troubleshot 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): 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: 50851072
• Report Number: 2016493-2026-64951
• Device Sequence Number: 9508428
• Product Code: BRY
• UDI-Device Identifier: 10885403512704
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 08/28/2026

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: 08/26/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2024
• 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