MAUDE Adverse Event Report: ICU MEDICAL, INC. CADD-SOLIS VIP AMBULATORY INFUSION PUMP; PUMP, INFUSION

Model Number	2120
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the pump repeatedly indicated the cassette was not attached properly and was reattached.There was unknown patient involvement, no patient injury was reported.
Additional Manufacturer Narrative
B3: unknown; no information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional information becomes available.
Additional Manufacturer Narrative
H3 and h6 codes, updated.One device was received for evaluation.Review of the event history log (ehl) showed a high alarm displayed: cassette not attached properly.No discrepancies related to the complaint were found during visual inspection.The customer reported issue was confirmed through the event log.During the functional testing, the issue was not duplicated.The probable cause of the reported problem was unknown.Service history review identified there was no indication that the complaint was related to a service of the device within the review period.Replaced the downstream occlusion (dso) sensor as a preventive maintenance.The device passed all functional tests after the repair.

• Brand Name: CADD-SOLIS VIP AMBULATORY INFUSION PUMP
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): ICU MEDICAL, INC.; 3350 granada avenue north; oakdale MN 55128
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 24818775
• Report Number: 3012307300-2026-03468
• Device Sequence Number: 5952328
• Product Code: FRN
• UDI-Device Identifier: 10610586042591
• UDI-Public: (01)10610586042591(11)180430
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2026

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: Health Professional
• Device Model Number: 2120
• Device Catalogue Number: 21-2120-0102-02
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/24/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2026
• Supplement Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 04/08/2026
• Supplement Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown