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	06/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was found during the investigation of a returned pump that an "error 41622" was identified in the event history log (ehl) this refers to a motor timeout error.This failure condition could potentially interrupt therapy and may stop the pump 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 an error 41622, alarm was identified.A review of 12-month service history performed, and no relevant findings were identified.Visual inspection and functional testing were performed.The customer-reported issue was confirmed through functional testing.The cause of the reported issue was determined to be a malfunctioning cam flex sensor, cam flex bracket.Upon further investigation, found dso seal delaminated.Replaced dso seal.Performed dso/uso sensor calibration.

• 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: 50855417
• Report Number: 3012307300-2026-08876
• Device Sequence Number: 9553959
• Product Code: FRN
• UDI-Device Identifier: 15019517126587
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

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: 21-2120-0104-01
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/16/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown