MAUDE Adverse Event Report: CAREFUSION 303, INC. BD PYXIS ANESTHESIA SYSTEM ES; AUTOMATED DISPENSING CABINET

Model Number	327
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that a pyxis anesthesia es system drawer handle completely came off when a user tried to open it, preventing users from removing medication and affecting patient care.There were no adverse events or injuries reported based on this event.
Additional Manufacturer Narrative
The customer requested for the complaint file to be closed as they had a spare handle available on site and installed themselves to resolve.
Event or Problem Description
It was reported by the customer that a pyxis anesthesia es system drawer handle completely came off when a user tried to open it, preventing users from removing medication and affecting patient care.There were no adverse events or injuries reported based on this event.
Additional Manufacturer Narrative
Corrections and or additional information has been added to the following sections: a1, d1, d4, d5, g2, g6, h2, h6, h11.A review of the complaint history for (b)(6) was performed in salesforce which did not locate similar complaints with the same failure mode for this serial number.A review of the device history record for (b)(6) was performed from 02-mar-2022 to 01-mar-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 drawer handle completely came off when a user tried to access.A field service engineer inspected the device and stated that the customer installed the spare by themselves to resolve the issue.The system functioned as intended after getting assessed by the customer and acknowledged by the field service engineer.

• Brand Name: BD PYXIS ANESTHESIA SYSTEM ES
• 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; 10020 pacific mesa blvd.; san diego CA 92121
• Manufacturer Contact: phillip emmert ; 10020 pacific mesa blvd.; san diego, CA 92130 ; 2105265020
• MDR Report Key: 18984735
• Report Number: 2016493-2024-00155
• Device Sequence Number: 20891009
• Product Code: BRY
• UDI-Device Identifier: 10885403477829
• UDI-Public: (01)10885403477829(21)13989679
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2025

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: 327
• Device Catalogue Number: 327KMAT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2024
• Supplement Date Received by Manufacturer: 03/01/2024
• Initial Report FDA Received Date: 03/27/2024
• Supplement Report FDA Received Date: 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2014
• 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