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

Model Number	2110
Medical Device Problem Codes	Defective Alarm (1014); Failure to Infuse (2340)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was stated that the pump was alarming that the cartridge was not engaged when its locked and the customer tried with few different cartridges.This is classified as a high-priority alarm and indicates that the disposable cartridge improperly attached.Although no patient involvement or harm was reported, the condition may recur during patient use and has the potential to stop the pump.There was no reported patient involvement.
Additional Manufacturer Narrative
One device was received for evaluation for the complaint that the pump was alarming that the cartridge was not engaged when its locked and the customer tried with few different cartridges.The review of event log found that the reported error occurred around 20 times in march 2026.There was no 12-month service history during the review.The visual and functional testing was performed.The complaint was confirmed during latch lock functional test.The complaint was also confirmed in the event log.The probable cause was the defective latch lock sensor, and the latch lock itself was replaced.The device passed all functional testing and performance verification tests within specification and with no failures.

• 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: 25150085
• Report Number: 3012307300-2026-04860
• Device Sequence Number: 9351353
• Product Code: FRN
• UDI-Device Identifier: 10610586041037
• UDI-Public: (01)10610586041037(11)171002
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/12/2026

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: 04/17/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/02/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown