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

Model Number	8110
Medical Device Problem Codes	Device Alarm System (1012); Circuit Failure (1089); Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2026
Type of Reportable Event	Malfunction
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 was obtained from servicing activities performed on the device.There were no additional details obtainable or provided at the time of service.
Event or Problem Description
It was reported that a failure was observed during a planned preventative maintenance, recall remediation, or repair order service event.Service type; error message ¿channel error¿ and unable to be used afterwards.There was no reported patient involvement.
Event or Problem Description
It was reported that a failure was observed during a planned preventative maintenance, recall remediation, or repair order service event."[depot repair]";"[error message ¿channel error¿ and unable to be used afterwards.]".There was no reported patient involvement.
Additional Manufacturer Narrative
Correction: annex b: b22 annex c: c20 annex d: d16 additional information: annex a: a0721, a020601 annex b: b01 annex c: c02, c07 annex d: d15 annex g: g0204002, g02005 a follow up report will be submitted with investigation results should the device be repaired or the device/logs be received for evaluation.This report lists imdrf annex a, c, d, and g codes that are reportable malfunctions observed on the device during servicing.Per 803.52(f)(11)(iii) the information provided was obtained from servicing activities performed on the device.There were no additional details obtainable or provided at the time of service.

• 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: 25407209
• Report Number: 2016493-2026-34688
• Device Sequence Number: 10326861
• Product Code: FRN
• UDI-Device Identifier: 10885403811036
• UDI-Public: (01)10885403811036
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K211218
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 09/02/2026

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: Other
• Device Model Number: 8110
• Device Catalogue Number: 8110 Alaris Syringe Module
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2026
• Supplement Date Received by Manufacturer: 06/09/2026; 07/14/2026; 08/04/2026; 09/02/2026
• Initial Report FDA Received Date: 06/05/2026
• Supplement Report FDA Received Date: 06/11/2026; 07/16/2026; 08/27/2026; 09/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/12/2019
• 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