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

Model Number	2110
Medical Device Problem Codes	Crack (1135); Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was stated that the device had damaged air sensor seal.There was no reported patient involvement.
Additional Manufacturer Narrative
B3: unknown; no information has been provided to date.H3: one device was received for evaluation.The service history review identified no related previous repairs in the last 12 months.The customer issue could not be replicated with the air sensor.Further investigation identified an unrelated issue to the customer's complaint where the downstream occlusion (dso) seal was cracking.The sea was replaced and the pump passed functional and accuracy testing thereafter.

• 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: 24053888
• Report Number: 3012307300-2026-00301
• Device Sequence Number: 18465028
• Product Code: FRN
• UDI-Device Identifier: 10610586041037
• UDI-Public: (01)10610586041037(11)170613
• 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): 01/13/2026

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: 12/22/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2025
• Initial Report FDA Received Date: 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2017
• 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