MAUDE Adverse Event Report: ICU Medical, Inc CADD Solis VIP Pump; Pump, infusion

Model Number	2120
Medical Device Problem Codes	Device Alarm System (1012); High Test Results (2457)
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 the pump failed the volume test, with a measured value of 22.80.The event occurred during testing.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 a "pump system fault 41622" alarm during delivery accuracy testing.A review of the 12-month service history found no relevant findings.Visual inspection and functional testing were performed; however, the customer-reported issue could not be confirmed.Further investigation identified a scratched lcd lens, a dented upstream occlusion (uso) seal, and a motor that continued running.The lcd lens, uso seal, and cam flex sensor were replaced.Following repair, the device passed all functional testing.

• Brand Name: CADD Solis VIP 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: 50897207
• Report Number: 3012307300-2026-08965
• Device Sequence Number: 5829406
• Product Code: FRN
• UDI-Device Identifier: 15019517084368
• UDI-Public: (01)15019517084368(11)160816
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other Health Care Professional
• 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: 21-2120-0103-01
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/16/2026
• Is the Reporter a Health Professional?: Yes
• 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: 08/16/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown