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

Model Number	338
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This initial medical device report (mdr) is being submitted late due to a retrospective review conducted through capa 10308384.The delay in submitting this mdr is due to the thorough and detailed nature of the retrospective review process.This process was essential to accurately capture all relevant data and ensure the integrity of our reporting.As recommended, we have included the capa reference for the retrospective review in the additional manufacturer narrative section.A review of the complaint history for sn (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 sn (b)(6) was performed from the date of manufacture, 01-aug-2014 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 station was not communicating, and the device was offline.A field service engineer found that the network cable needs to be replaced.The hospital information technology department resolved port and virtual local area network communication issue.After waiting for the room to become available, network and cable connections were fixed, the station began communicating with the console, rebooted multiple times, and the ip address was verified.The system functioned as intended after the field service engineer troubleshot the device.
Event or Problem Description
It was reported by the customer that a bd pyxis¿ anesthesia station 4000 was not communicating, and device was in offline.The customer tried to reboot and recover, but the issue persisted.The customer added this malfunction caused a delay in dispensing the medication to the patient since they had to get the medications from another station.There were no adverse events or injuries reported based on this incident.

• 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: 21908796
• Report Number: 2016493-2025-76312
• Device Sequence Number: 4221784
• Product Code: BRY
• UDI-Device Identifier: 10885403477829
• UDI-Public: (01)10885403477829
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 04/23/2025

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: 06/11/2022
• Initial Report FDA Received Date: 04/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2014
• 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
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown