MAUDE Adverse Event Report: ICU Medical, Inc. CADD Solis HPCA Pumps; 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	06/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The device was returned for evaluation following a report of a downstream occlusion sensor malfunction.The results of the investigation confirmed that the dso sensor was defective.There was no patient involvement or patient harm.
Additional Manufacturer Narrative
The suspect pump was returned for evaluation.The event history log (ehl) was reviewed, and a "cassette not attached properly" alarm was 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 through pci functional testing.During testing, the pump generated error code 46440, which was related to the dso sensor.The probable cause of the reported issue was determined to be a defective dso sensor.The dso sensor and dso seal were replaced.Upon further investigation, the pwa board connector was found to be damaged.The pwa board was replaced.Dso/uso sensor calibration was performed, and the software was reloaded and updated to the latest revision.The device passed all functional and delivery tests following completion of the repair activities.

• 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: 50887515
• Report Number: 3012307300-2026-08927
• Device Sequence Number: 10704918
• Product Code: MEA
• UDI-Device Identifier: 15019517099690
• UDI-Public: (01)15019517099690(11)180501
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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: 07/22/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown