MAUDE Adverse Event Report: CAREFUSION 303, INC. BD PYXIS¿ MEDSTATION¿ 4000 INTEGRATED MAIN; AUTOMATED DISPENSING CABINET

Model Number	500001002002
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2026
Type of Reportable Event	Malfunction
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, 22-jul-2011 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 system drawer 12 produced a clicking sound and failed to open.A field service engineer (fse) replaced the solenoid unit plunger with a round clip on auxiliary station matrix drawer 6.The pharmacist then successfully recovered the failed drawer, confirming normal operation and resolving the issue.The system functioned as intended after the field service engineer repaired the device.
Event or Problem Description
It was reported that when using the bd pyxis¿ medstation¿ 4000 integrated main system drawer 12 produced a clicking sound and failed to open.The customer reported that the drawer appeared to be jammed.The customer tried to recover but the issue persisted.The customer stated that this malfunction occurred while dispensing the medication.There were no adverse events or injuries reported based on this event.

• Brand Name: BD PYXIS¿ MEDSTATION¿ 4000 INTEGRATED MAIN
• Common Device Name: AUTOMATED DISPENSING CABINET
• Manufacturer (Section D): CAREFUSION 303, INC.; 3750 torrey view ct; san diego CA 92130
• Manufacturer (Section G): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: brett wilko ; 3750 torrey view ct; san diego, CA 92130 ; 8586172000
• MDR Report Key: 25648901
• Report Number: 2016493-2026-40834
• Device Sequence Number: 9750181
• Product Code: BRY
• UDI-Device Identifier: 10885403512636
• UDI-Public: (01)10885403512636
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 06/04/2026

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: 500001002002
• Device Catalogue Number: 306
• 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: 05/31/2026
• Initial Report FDA Received Date: 06/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2011
• 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
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown