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

Model Number	8110
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient was receiving prostin via a picc line using a syringe pump module (channel c) when a discrepancy in infusion volume was noted.After resetting the ¿volume infused¿ to track hourly delivery, the rn observed 0.05ml infused at ~0920 before going on a break.Upon return at 1000, the volume infused display was blank despite the pump indicating the infusion was ongoing, preventing confirmation of delivered medication.At ~1030, the display reappeared but showed 0ml infused, leaving the amount administered during that period unknown.The pump functioned normally again after 1100 but was replaced due to safety concerns.There was patient involvement, but no harm.Biomed received the pcu and later identified the associated syringe pump module, though no syringe or tubing was available for evaluation.The issue could not be replicated, and investigation is ongoing.
Additional Manufacturer Narrative
A follow up report will be submitted with investigation results should the device be repaired or the device/logs be received for evaluation.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: 25521547
• Report Number: 2016493-2026-37545
• Device Sequence Number: 18779850
• 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,Followup,Followup
• Report Date (Section B): 08/14/2026

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?: No
• 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: 05/29/2026
• Supplement Date Received by Manufacturer: 07/14/2026; 08/14/2026
• Initial Report FDA Received Date: 06/16/2026
• Supplement Report FDA Received Date: 07/16/2026; 08/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/30/2023
• 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.
• Patient Sex: Unknown