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

Model Number	2110
Medical Device Problem Code	Pumping Problem (3016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during testing pump giving error 41622 after the first pump sequence.The event occurred during testing.During the investigation, it was confirmed that the high-priority error 41622 "error_motor_timeout" was displayed and recorded in the event log of the returned pump.This failure occurred during testing; however, if it were to recur during infusion, it could result in an interruption of therapy.There are no patient involvement and adverse event reported. .
Additional Manufacturer Narrative
The suspect pump was returned for evaluation, and the event history log (ehl) was reviewed.An error code 41622 was identified in the event log.A review of the 12-month service history found no prior service records.Visual and functional inspections revealed a contaminated uso seal, and the device failed the motor test, downstream occlusion test, upstream occlusion sensor test, and battery fall-out test.The reported issue was confirmed during the evaluation, and the root cause was determined to be a defective flex sensor.Corrective action includes replacement of the uso seal and cam flex sensor.

• 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: 50844128
• Report Number: 3012307300-2026-08844
• Device Sequence Number: 10039823
• Product Code: MEA
• UDI-Device Identifier: 15019517154290
• UDI-Public: (01)15019517154290(11)240502
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

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: 07/14/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown