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

Model Number	338
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported that a pyxis anesthesia 4000 system biometric scanner unexpectedly stopped responding during a procedure, delaying user access to medication.The nature of the procedure and the length of the delay were not disclosed.Patient or user harm was not reported.
Additional Manufacturer Narrative
Customer reported that a pyxis anesthesia 4000 system biometric scanner unexpectedly stopped responding during a procedure, delaying user access to medication.The nature of the procedure and the length of the delay were not disclosed.Patient or user harm was not reported.This event is recorded in complaint (b)(4).A field service associate evaluated the device and determined, after testing, that the station's biometric scanner required replacement.The field service associate installed the replacement biometric scanner to resolve.Device confirmed operational by customer.
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 30-aug-2020 to 30-aug-2022 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 bio id scanner for the device was not responding during a procedure.A field service engineer found the bio id scanner to be faulty and successfully repaired it.The system functioned as intended after the field service engineer troubleshot the device.The following fields have been updated with additional information: a1 patient identifier d4 model #, catalog #, and udi # d5 operator of device e1 initial reporter facility name: el camino hospital - mountain view campus e3 initial reporter occupation h6 - investigation codes.
Event or Problem Description
It was reported that a pyxis anesthesia 4000 system biometric scanner unexpectedly stopped responding during a procedure, delaying user access to medication.The nature of the procedure and the length of the delay were not disclosed.There was no report of impact on the patient or user during this event.

• Brand Name: PYXIS ANESTHESIA SYSTEM 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; 10020 pacific mesa boulevard; san diego CA 92121
• Manufacturer Contact: phillip emmert ; 10020 pacific mesa blvd.; san diego, CA 92130
• MDR Report Key: 15494221
• Report Number: 2016493-2022-99163
• Device Sequence Number: 1905140
• 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,Followup
• Report Date (Section B): 02/17/2025

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: Health Professional
• Device Model Number: 338
• Device Catalogue Number: 338KMAT
• 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: 08/30/2022
• Supplement Date Received by Manufacturer: 08/30/2022
• Initial Report FDA Received Date: 09/27/2022
• Supplement Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2014
• 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