MAUDE Adverse Event Report: ICU Medical, Inc. CADD Solis Ambulatory Infusion Pump; Pump, Infusion

Catalog Number	21-2112-0402-09JP
Medical Device Problem Code	Failure to Infuse (2340)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that pump triggered blockage alarm.This high-priority error occurred during patient use; there was a patient involvement, but no patient harm or adverse event reported.However, if this error reoccurs during infusion, it may interrupt therapy.
Additional Manufacturer Narrative
B3 - date of event is unknown.E1 - initial reporter phone (b)(6).Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional information becomes available.

• Brand Name: CADD Solis Ambulatory Infusion Pump
• Common Device Name: Pump, Infusion
• 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: 50867176
• Report Number: 3012307300-2026-08898
• Device Sequence Number: 21177083
• Product Code: MEA
• UDI-Device Identifier: 15019517154993
• UDI-Public: (01)15019517154993
• Combination Product (Y/N): N
• Initial Reporter State: NA
• Initial Reporter Country: JA
• 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,User Facility
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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 Catalogue Number: 21-2112-0402-09JP
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/07/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown