MAUDE Adverse Event Report: ICU MEDICAL, INC. CADD SOLIS VIP 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	09/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspected device was returned for evaluation.The event history log (ehl) was reviewed there were no errors related to the customer complaint.The device was visually inspected.A functional test was performed and the reported issue was confirmed.The probable cause of the reported issue was due to the downstream occlusion sensor.As a result, the downstream occlusion seal/sensor was replaced.The service history review had no indication that the complaint was related to a service of the device within the review period.The device passed all functional testing after repair.
Event or Problem Description
It was reported that the pump exhibited a cassette not attached properly alarm.Alarm did not clear when the cassette was attached.During physical inspection, it was found that there was a downstream occlusion sensor issue.There was no patient involvement, no injury was reported.

• Brand Name: CADD SOLIS VIP PUMP
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): ICU MEDICAL, INC.; 3350 granada ave n; oakdale MN 55128
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 23514113
• Report Number: 3012307300-2025-12295
• Device Sequence Number: 9732837
• Product Code: FRN
• UDI-Device Identifier: 15019517084368
• UDI-Public: (01)15019517084368(11)190513
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/10/2025

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: 21-2120-0103-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 11/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2019
• 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