MAUDE Adverse Event Report: CAREFUSION 303, INC. ALARIS SYSTEM; PUMP, INFUSION

Model Number	8110
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device history record, complaint history review, and risk review on failure modes are performed on each device with reportable malfunction(s) along with other methods of investigation as coded in section h6 of this mdr report.Root cause: the root cause for the reported issue that device had error codes 211.2 and 221.201 was not determined because no product or device logs were returned.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.
Event or Problem Description
It was reported that the customer is encountering and increased number channel errors when connecting the device to the pcu.Common error codes seen are 211.2 and 221.201.Customer has conducted preliminary testing and states that after flashing the pump, the device will operate normally for a few minutes, after which the same channel error will reappear.The customer has replaced the logic board in many of the devices.Following logic board replacement, the device will operate as normal, without channel errors.There was no patient involvement.

• 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 SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: brett wilko ; 3750 torrey view ct; san diego, CA 92130 ; 8586172000
• MDR Report Key: 25168065
• Report Number: 2016493-2026-28771
• Device Sequence Number: 18772678
• Product Code: FRN
• UDI-Device Identifier: 10885403811036
• UDI-Public: (01)10885403811036
• Combination Product (Y/N): N
• Initial Reporter Country: QA
• PMA/510(K) Number: K072105
• 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
• Report Date (Section B): 04/27/2026

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
• 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: 04/21/2026
• Initial Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/03/2019
• 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