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

Model Number	2120
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect pump was returned for evaluation.The event history log (ehl) was reviewed.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 was confirmed through the downstream occlusion test.The cause of the reported issue was determined to be a defective dso sensor.Dso sensor was replaced to resolve issues.Performance verification testing (pvt) was performed, and the unit passed all testing criteria.
Event or Problem Description
It was identified during the inspection of the returned pump that the event log contained the error message, ¿cassette not attached properly.¿ this high-priority error was observed during testing.Although no issues were reported during patient use, recurrence of this error during an infusion could interrupt therapy.There was no patient involvement associated with this event, and no patient harm was reported.

• 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: 50903163
• Report Number: 3012307300-2026-08997
• Device Sequence Number: 10712014
• Product Code: FRN
• UDI-Device Identifier: 15019517150001
• UDI-Public: (01)15019517150001(11)200701
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: 21-2120-0105-01
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/28/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown