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	08/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device had alarmed with error code 42224, a high-priority alarm which if recur during use can interrupt therapy.This event resolved with tech support.There was no reported patient involvement and harm.
Additional Manufacturer Narrative
No product was returned.The reported issue cannot be confirmed as no product was returned for investigation.If the product is returned, this complaint will be reopened for further investigation.The service history review identified no indication that the complaint was related to a service of the device within the review period.

• 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: 50817672
• Report Number: 3012307300-2026-08790
• Device Sequence Number: 18694622
• Product Code: MEA
• UDI-Device Identifier: 15019517099690
• UDI-Public: (01)15019517099690(11)180518
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/18/2026

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?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/18/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown