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

Model Number	2120
Medical Device Problem Code	Pumping Problem (3016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was found during the investigation of a returned pump that the customer-reported issue involving a "cassette not properly attached" alarm was confirmed through investigation testing.This alarm condition is associated with a high-priority alarm and could potentially interrupt therapy if it occurs during patient use.There was no patient involvement or harm.
Additional Manufacturer Narrative
The suspect pump was returned for evaluation.The event history log (ehl) was reviewed, and a "cassette not attached properly" alarm was identified.A review of the 12-month service history was conducted and revealed two previous service events related to cassette alarms.Visual inspection and functional testing were performed.The customer-reported issue was confirmed through review of the a/d screen, the 50 ml test, and the event log.The probable cause of the reported issue was determined to be a defective dso sensor.The dso sensor was replaced.Upon further investigation, the uso seal was found to be buckled, and the battery door was found to be cracked.The uso seal and battery door were replaced.Dso/uso sensor calibration was performed.Performance verification testing (pvt) was completed, and the unit passed all testing criteria.The software was updated to the latest revision.

• 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: 50949019
• Report Number: 3012307300-2026-09057
• Device Sequence Number: 9624471
• Product Code: FRN
• UDI-Device Identifier: 15019517150001
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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: 08/31/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown