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	02/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3/h6: the suspected device was returned for evaluation.Review of the event history log (ehl) was performed.The device was visually inspected.A functional test was performed, and the reported issue was confirmed through occlusion test.The cause of the reported issue was unknown.Upon further investigation, found dso seal delaminated and lens damaged.As a result, replaced dso seal and lcd lens.The service history review had no indication that the complaint was related to a service of the device within the review period.The device passed all functional testing after repair.
Event or Problem Description
The customer reported that the pump alarm indicated the cassette was not connected correctly.There was no reported patient involvement and harm.Evaluation of the returned device confirmed the reported issue.This led to interruption of therapy while in use.

• Brand Name: CADD SOLIS HPCA PUMPS
• Common Device Name: PUMP, INFUSION, PCA
• Manufacturer (Section D): ICU MEDICAL, INC.; 3350 granada avenue north,; oakdale MN 55128
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 24589948
• Report Number: 3012307300-2026-02381
• Device Sequence Number: 18376080
• Product Code: MEA
• UDI-Device Identifier: 15019517101003
• UDI-Public: (01)15019517101003(11)190615
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 03/13/2026

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: 21-2112-0401-51
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown