MAUDE Adverse Event Report: ICU Medical, Inc. CADD-Solis HPCA Pump; 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 cadd-solis pump generated an upstream occlusion alarm despite no occlusion being present.The event occurred during infusion.There was patient involvement; however, no patient harm or adverse event was reported.
Additional Manufacturer Narrative
E1 - initial reporter phone- (b)(6).The suspect pump was returned for evaluation.The event history log (ehl) was reviewed, and a review of the 12-month service history was conducted; however, no relevant findings were identified.Visual inspection and functional testing were performed.The customer-reported issue could not be replicated, as no faults were identified with the upstream occlusion sensor during evaluation.The pump passed all functional testing.

• 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: 50803900
• Report Number: 3012307300-2026-08766
• Device Sequence Number: 8543033
• Product Code: MEA
• UDI-Device Identifier: 15019517154993
• UDI-Public: (01)15019517154993(11)230119
• Combination Product (Y/N): N
• Initial Reporter State: NA
• Initial Reporter Country: AS
• 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: Foreign,Health Professional,User Facility
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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: 08/24/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1667-1668-2025
• Patient Sequence Number: 1
• Patient Sex: Unknown