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

Model Number	8110
Medical Device Problem Codes	Pumping Stopped (1503); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that three pumps involved in an incident and the entire set shut down on its own.The patient was receiving an infusion of heparin (1unit/ml in 0.45% nacl) at a rate of 1ml / hour the event occurred between 2300-0100 hours.The devices were plugged into ac power at the time of the event.Picc line was flushed and subsequently had to be replaced but no harm to the patient.
Additional Manufacturer Narrative
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: 25530731
• Report Number: 2016493-2026-37660
• Device Sequence Number: 15852568
• Product Code: FRN
• UDI-Device Identifier: 10885403811043
• UDI-Public: (01)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: Health Professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2026

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: 8110
• Device Catalogue Number: 8110 Alaris Syringe Module
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/08/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2026
• Supplement Date Received by Manufacturer: 07/28/2026
• Initial Report FDA Received Date: 06/17/2026
• Supplement Report FDA Received Date: 07/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2017
• 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