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

Model Number	2110
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspected device was returned for evaluation.The device was visually inspected and found that there was cracked downstream occlusion (dso) seal.During the functional testing, the customer reported issue was confirmed.The cause of the reported problem was faulty mainboard.The dso seal and mainboard were replaced to correct the issue.The service history review had no indication that the complaint was related to a service of the device within the review period.The device passed all functional testing after repair.
Event or Problem Description
The customer returned the device stating, "the remote dose socket was not functional".During device evaluation it was found the downstream occlusion (dso) seal was cracked.

• 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 north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 23991943
• Report Number: 3012307300-2026-00197
• Device Sequence Number: 10536290
• Product Code: FRN
• UDI-Device Identifier: 10610586041037
• UDI-Public: (01)10610586041037(11)160425
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 01/07/2026

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: 2110
• Device Catalogue Number: 21-2111-0400-51
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 01/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2016
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown