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

Model Number	2120
Medical Device Problem Code	Inaccurate Flow Rate (1249)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during testing, the failed the downstream occlusion (dso) pressure test, with a measured pressure value of 8.47 psi.There was no patient involvement associated with this event, and no patient harm was reported.
Additional Manufacturer Narrative
The suspect pump was returned for evaluation.Review of the event history log (ehl) identified no events related to the reported issue.A review of the 12-month service history confirmed that the device had not undergone servicing during this period.Visual inspection revealed a torn downstream occlusion (dso) seal and a dented upstream occlusion (uso) seal.Functional testing was performed to evaluate the reported failure of the downstream occlusion (dso) pressure test; however, the issue could not be replicated.The dso sensor and uso seal were replaced as part of the repair.The probable cause of the reported issue could not be determined.Following repair, the device passed all functional testing.

• Brand Name: CADD-Solis VIP 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: 50897072
• Report Number: 3012307300-2026-08962
• Device Sequence Number: 10684697
• Product Code: FRN
• UDI-Device Identifier: 15019517126587
• UDI-Public: (01)15019517126587(11)180518
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K111275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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: 2120
• Device Catalogue Number: 21-2120-0104-01
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/16/2026
• 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: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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