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

Model Number	8015
Medical Device Problem Code	Inaccurate Delivery (2339)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient was receiving a continuous bivalirudin infusion that was ordered to run at 0.158 mg/kg/hr.The infusion was started at the correct rate 0.158 mg/kg/h (12.6 ml/hr) via interoperability.It was later discovered running at the incorrect rate of 0.1593 mg/kg/hr (12.7 ml/hr) for approximately two hours starting at 5:41am.There was patient involvement and no harm.Additional information provided 02sep2026: per review of the event logs, it appears that the clinician inadvertently pressed the "up arrow" key prior to pressing start at 05:41:17.This increased the rate from 12.6 ml/hr to 12.7 ml/hr.
Additional Manufacturer Narrative
Bd technical support troubleshoot with customer over the phone.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: 50850121
• Report Number: 2016493-2026-64921
• Device Sequence Number: 9953254
• Product Code: FRN
• UDI-Device Identifier: 10885403801549
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K072105
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/08/2026

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: 8015
• Device Catalogue Number: 8015 Alaris PCU 1.5 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: 09/01/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/02/2019
• 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
• Patient Sex: Unknown