MAUDE Adverse Event Report: ICU MEDICAL, INC. CADD-SOLIS AMBULATORY INFUSION PUMP; PUMP, INFUSION

Model Number	2110
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: the device was received for evaluation.Service history review identified there was no indication that the complaint was related to a service of the device within the review period.Visual and functional tests were performed.The customer's stated problem was not confirmed.The pump was delivering within specification.There was no known cause of the reported issue, and no further action was taken.
Event or Problem Description
It was reported that the device had delivered bolus volume too high, required calibration.There was no patient involvement.

• Brand Name: CADD-SOLIS AMBULATORY INFUSION PUMP
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): ICU MEDICAL, INC.; 3350 granada avenue north; oakdale MN 55128
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 24471454
• Report Number: 3012307300-2026-01808
• Device Sequence Number: 9361045
• Product Code: FRN
• UDI-Device Identifier: 10610586041037
• UDI-Public: (01)10610586041037(11)180604
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K111275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 02/27/2026

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: Health Professional
• Device Model Number: 2110
• Device Catalogue Number: 21-2111-0400-51
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown