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	06/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was found during the investigation of a returned pump that the customer complaint regarding the device displaying the error message, "cassette not attached properly.Reattach cassette," despite the cassette being properly attached, was confirmed through investigation testing.This error code triggers a high-priority alarm, and this issue could potentially interrupt therapy.There was no patient involvement and no harm was reported.
Additional Manufacturer Narrative
The suspected device was returned for evaluation.The review of event log performed and found nothing related to complaint.A review of the available service history identified no previous related repairs within the last 12 months.The visual inspection and functional testing were performed, and defective downstream occlusion (dso) sensor was found and replaced.The customer complaint was confirmed.Additionally, the investigation identified a damaged uso seal, battery compartment, and defective main board, all of which were replaced.The downstream occlusion (dso) and upstream occlusion (uso) sensors were calibrated.The device passed all functional testing after repair.The software was updated, and the device was reset to its standard configuration.

• 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: 50899846
• Report Number: 3012307300-2026-08975
• Device Sequence Number: 5903728
• Product Code: FRN
• UDI-Device Identifier: 15019517096378
• UDI-Public: (01)15019517096378(11)170317
• 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: 21-2120-0103-51
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/15/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown