MAUDE Adverse Event Report: CAREFUSION 303, INC. Alaris System; Pump, Infusion

Model Number	8120
Medical Device Problem Code	Fail-Safe Problem (2936)
Health Effect - Clinical Code	Loss of consciousness (2418)
Date of Event	08/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was initially reported the customer requested a log review for a possible tampering/diversion event.Fentanyl pca was programmed (b)(6)2026 and the pca door was found unlocked.Additional information received through due diligence attempts on (b)(6)2026: per report, the customer stated a suspected tampering/diversion event occurred on (b)(6)2026 at approximately 0600 when a clinician caring for the patient was found unconscious in a bathroom and subsequently admitted to withdrawing volume from a fentanyl pca syringe and self-administering the medication.The clinician had worked from (b)(6)2026 1900 to (b)(6)2026 0700 and returned for a shift from (b)(6)2026 1900 until being discovered the following morning.The customer reported that the suspected tampering occurred shortly after the fentanyl syringe was installed based on a discrepancy between the expected and observed volume to be infused (vtbi) displayed by the pca module.The fentanyl pca was programmed as a continuous infusion titratable from 0 to 200 mcg/hr with no bolus doses enabled.Naloxone was administered to the clinician, who was transported to the emergency department for further evaluation and treatment.
Additional Manufacturer Narrative
B1: adverse event and product problem.The event logs have been received and the evaluation is pending.A follow up report will be submitted with investigation results once the evaluation has been completed.Per 803.52(f)(11)(iii) the information provided represents all of the known information at this time.The complainant or reporter was unable or unwilling to provide any further patient, product, or procedural details to the manufacturer.

• Brand Name: Alaris System
• Common Device Name: Pump, Infusion
• Manufacturer (Section D): CAREFUSION 303, INC.; 3750 torrey view ct; san diego CA 92130
• Manufacturer (Section G): CareFusion 303, INC.; 10020 pacific mesa blvd; san diego CA 92121 -438
• Manufacturer Contact: brett wilko ; 3750 torrey view ct; san diego, CA 92130 ; +1(858)617-2000
• MDR Report Key: 50850123
• Report Number: 2016493-2026-64919
• Device Sequence Number: 21320415
• Product Code: MEA
• UDI-Device Identifier: 10885403516030
• UDI-Public: (01)10885403516030
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K211218
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 09/07/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 8120
• Device Catalogue Number: 8120 Alaris PCA Module
• 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: 08/28/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/20/2024
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 8015
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown