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	Insufficient Information (4580)
Date of Event	05/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was an event where a patient was receiving a continuous intravenous heparin infusion experienced an unintended rapid infusion event.The heparin infusion was ordered and programmed to run at 1,150 units/hour in accordance with the established heparin protocol.A new heparin bag was initiated at 1214 hours following independent dose and rate verification by two registered nurses using the patient¿s most recent ptt result.The infusion pump was programmed to deliver heparin at 1,150 units/hour.During the scheduled infusion check at 1315 hours, nursing staff noted the heparin bag was nearly empty despite the prescribed infusion rate.The pump alarmed at this time, and the infusion was immediately stopped.A second nurse independently reviewed the pump programming and confirmed that the programmed settings were correct.The patient was assessed immediately following identification of the event.No signs or symptoms of bleeding were present, and vital signs remained stable.The responsible medical team, charge nurses, and unit manager were notified.The heparin infusion was held, and urgent coagulation studies were obtained.Protamine 100 mg iv was administered as a reversal agent under close monitoring, with no adverse effects observed during administration.Subsequent coagulation studies demonstrated ptt values greater than 169 seconds on three separate samples, prompting consultation with hematology.Ongoing serial coagulation monitoring was completed, and the ptt normalized to 34.9 seconds by 1904 hours.Following hematology consultation and reassessment by the medical team, the heparin infusion was restarted at the original prescribed rate of 1,150 units/hour per protocol.There was patient involvement, however outcome is unknown.On 24jul2026, the customer provided additional information indicating that they had determined the issue was "user error.".
Additional Manufacturer Narrative
B1: adverse event and product problem.A follow up report will be submitted once the failure investigation 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: 50249313
• Report Number: 2016493-2026-54762
• Device Sequence Number: 10025448
• Product Code: FRN
• UDI-Device Identifier: 10885403801549
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K072105
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/31/2026

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: 8015
• Device Catalogue Number: 8015 Alaris PCU 1.5 Module
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/20/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2026
• Initial Report FDA Received Date: 08/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/05/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown