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

Model Number	8110
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	Decreased Level of Consciousness (4591)
Date of Event	08/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a pediatric icu patient was noted at the start of shift to be significantly less responsive than on prior days despite decreasing sedation in preparation for extubation.The nurse stopped the morphine infusion and later dexmedetomidine and subsequently observed that the morphine syringe contained far less medication than expected.Clinical findings, including decreased responsiveness, urinary retention, rising co2 levels, ventilator support requirements, constricted pupils, and reduced cough strength, were consistent with opioid toxicity.Although naloxone was initially deferred, administration of 0.05 mg naloxone later that day resulted in immediate improvement in alertness, eye tracking, responsiveness, and cough/gag reflexes, confirming opioid effect as the likely cause of the altered mental status.Biomedical engineering investigated the syringe infusion pump module and found no pump programming errors, alarms, or equipment faults.A cracked morphine syringe was identified, with the defect located beneath the syringe label and difficult to detect visually.Customer testing demonstrated that air could enter through the crack, allegedly allowing medication to flow into the patient by gravity without detection by the syringe pump.Replication testing by the customer showed approximately 20 ml of fluid allegedly infused unintentionally in less than two hours, and complete leakage occurred overnight.Preventive maintenance on the pump revealed no defects.Customer concluded the defective syringe caused may have contributed to the unintended morphine overinfusion.
Additional Manufacturer Narrative
B1: adverse event and product problem a device history record, complaint history review, and risk review on failure modes are performed on each device with reportable malfunction(s) along with other methods of investigation as coded in section h6 of this mdr report.Root cause: the root cause for the reported issue that device had over infusion was not determined because no product or device logs were returned.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): Sistemas Medicos Alaris S.A de C.V.; parque sur, el realito; blvd. 2000; tijuana 22250 ; MX 22250
• Manufacturer Contact: brett wilko ; 3750 torrey view ct; san diego, CA 92130 ; +1(858)617-2000
• MDR Report Key: 50685190
• Report Number: 2016493-2026-61402
• Device Sequence Number: 5155281
• Product Code: FRN
• UDI-Device Identifier: 10885403811043
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K211218
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 08/31/2026

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: 8110
• Device Catalogue Number: 8110 Alaris Syringe Module
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2026
• Initial Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/08/2025
• 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