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

Model Number	2110
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during testing, the device alarmed indicating that the cassette was partially unlatched after the cassette had been inserted, the door closed, and the cassette locked.During investigation testing, a defective latch lock sensor was confirmed.There was no patient involvement associated with this event, and no patient harm was reported.However, if this issue were to recur during infusion, the pump may not operate as intended and therapy could be interrupted.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.Review of the event history log (ehl) identified a "cassette partially unlatched" error in the event history.A review of the device records found no available 12-month service history.Visual inspection revealed no anomalies related to the reported complaint.Functional testing, including a latch lock test, confirmed a faulty latch sensor, thereby confirming the reported issue.The latch sensor was replaced as part of the repair.The probable cause of the reported issue was determined to be a faulty cassette latch sensor.Following repair, the device passed all functional testing.

• Brand Name: CADD Solis HPCA Pump
• 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: 50897812
• Report Number: 3012307300-2026-08968
• Device Sequence Number: 10684188
• Product Code: MEA
• UDI-Device Identifier: 15019517154290
• UDI-Public: (01)15019517154290(11)240405
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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: 21-2111-0402-51
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/22/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown