MAUDE Adverse Event Report: ICU Medical, Inc. CADD Solis HPCA Pumps; Pump, infusion, pca

Model Number	2110
Medical Device Problem Code	Failure to Infuse (2340)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device generated an "air in line" alarm during normal clinical use.This alarm condition is associated with a high-priority alarm and could potentially interrupt therapy if it occurs during patient use.Patient involvement is unknown; however, no patient harm or adverse event was reported.
Additional Manufacturer Narrative
The suspect pump was returned for evaluation.The event history log (ehl) was reviewed, and multiple "air in line" alarms were identified.A review of the 12-month service history was conducted, and no relevant findings were identified.Visual inspection and functional testing were performed.The customer-reported issue was confirmed.The cause of the reported issue was determined to be a faulty air sensor.The air sensor was replaced, and the pump was restored to proper functionality.

• Brand Name: CADD Solis HPCA Pumps
• Common Device Name: Pump, infusion, pca
• Manufacturer (Section D): ICU Medical, Inc.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; +1(224)706-2300
• MDR Report Key: 50594286
• Report Number: 3012307300-2026-08487
• Device Sequence Number: 9451655
• Product Code: MEA
• UDI-Device Identifier: 15019517099690
• UDI-Public: (01)15019517099690(11)190305
• Combination Product (Y/N): N
• Initial Reporter State: NA
• Initial Reporter Country: AS
• PMA/510(K) Number: K170982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/03/2026

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: 21-2111-0401-51
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/07/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown