MAUDE Adverse Event Report: CAREFUSION 303, INC. BD PYXIS¿ ANESTHESIA STATION 4000; AUTOMATED DISPENSING CABINET

Model Number	338
Medical Device Problem Code	Failure to Eject (4010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2025
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, 05-jun-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 mini drawer 1.5 didn't open and stuck in the closed position.A field service engineer (fse) observed that one of the mini pockets had been pushed in.Fse opened the back panel and unlocked the top row of mini pockets.Using a screwdriver, carefully pried the pocket forward, though it moved with noticeable hesitation.Fse found that packets of medication were stored in small zip lock bags and were sticking up above the 12-pocket height, obstructing the drawer¿s movement.The customer was able to fold and tape the packets down to prevent further obstruction.The system functioned as intended after the field service engineer investigated the device.
Event or Problem Description
It was reported that when using the bd pyxis¿ anesthesia station 4000, the mini drawer would not open.The customer reported that there was a delay in dispensing the medication.There were no adverse events or injuries reported based on this event.

• Brand Name: BD PYXIS¿ ANESTHESIA STATION 4000
• Common Device Name: AUTOMATED DISPENSING CABINET
• Manufacturer (Section D): CAREFUSION 303, INC.; 10020 pacific mesa blvd.; san diego CA 92130
• Manufacturer (Section G): CAREFUSION 303, INC.; 10020 pacific mesa blvd.; san diego CA 92130
• Manufacturer Contact: brett wilko ; 10020 pacific mesa blvd.; san diego, CA 92130
• MDR Report Key: 22413598
• Report Number: 2016493-2025-93720
• Device Sequence Number: 13180053
• Product Code: BRY
• UDI-Device Identifier: 10885403477829
• UDI-Public: (01)10885403477829
• 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): 07/04/2025

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: 338
• Device Catalogue Number: 338
• 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: 06/10/2025
• Initial Report FDA Received Date: 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2017
• 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
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown