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

Model Number	2110
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was found during the investigation of a returned pump that an error "41622" was pops up as soon as the pump turns on due to faulty flex sensor.This failure condition could potentially interrupt therapy and may stop the pump if it occurs during patient use.There was no patient involvement or harm.
Additional Manufacturer Narrative
The device was returned for evaluation.Visual inspection identified a missing battery door.The device event log and 12-month service history were reviewed.Functional testing confirmed error code 41622 upon pump power-up.Replacement of the flex sensor resolved the reported issue.During further testing, error code 46440 was observed and resolved by replacing the dso sensor.The root cause of the reported 41622 error was determined to be a faulty 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: 50855301
• Report Number: 3012307300-2026-08874
• Device Sequence Number: 13242653
• Product Code: MEA
• UDI-Device Identifier: 15019517154993
• UDI-Public: (01)15019517154993(11)240606
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

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: 21-2112-0402-51
• 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: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown