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

Model Number	500400002000
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Loose or Intermittent Connection (1371); Application Program Problem (2880)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that when using the bd pyxis¿ anesthesia station 4000 the bio id had failed.The customer stated that there was a delay in patient care.There were no adverse events or injuries reported due to this event.
Additional Manufacturer Narrative
Additional information: section h imdrf annex codes.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, 17-feb-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 biometric identifier device repeatedly failed.The field service engineer (fse) updated serial number in remote support service (rss), bio-id connections were reset, the lens was cleaned, and firmware was updated.The device was tested and confirmed to be operating correctly.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¿ anesthesia station 4000 the bio id had failed.The customer stated that there was a delay in patient care.There were no adverse events or injuries reported due to this event.

• Brand Name: BD PYXIS¿ MEDSTATION¿ 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 SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: brett wilko ; 10020 pacific mesa blvd.; san diego, CA 92130
• MDR Report Key: 23413542
• Report Number: 2016493-2025-127532
• Device Sequence Number: 16019546
• Product Code: BRY
• UDI-Device Identifier: 10885403477829
• UDI-Public: (01)10885403477829
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2025

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: 500400002000
• 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: 10/01/2025
• Supplement Date Received by Manufacturer: 11/01/2025
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 11/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2017
• 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