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

Model Number	2120
Medical Device Problem Codes	Failure to Infuse (2340); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer returned the device stating, "during preventive maintenance pump has error code 41786".Upon device evaluation the error was noted on event history log, and additionally downstream occlusion seal was noted to be detached.This issue may lead to fluid ingress.There was no patient involvement and no harm.
Additional Manufacturer Narrative
E1 - (b)(6).One suspected device was received for evaluation.The event history log (ehl) was reviewed and alarm 41786 were noted on the ehl as complainant states.Service history review identified there was no indication that the complaint was related to a service of the device within the review period.The customer complaint was confirmed through ehl.Charged the pump for minimum of 3 days and after it was able to maintain date and time.The probable root cause was due to the uncharged coin battery.Upon additional inspection, the downstream occlusion seal (dso) was detached.Replaced dso seal.The device passed all functional and delivery tests performed after repair activities.

• 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: 50484992
• Report Number: 3012307300-2026-08355
• Device Sequence Number: 10093976
• Product Code: FRN
• UDI-Device Identifier: 15019517126600
• UDI-Public: (01)15019517126600(11)190719
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/27/2026

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: 21-2127-0104-01
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/16/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2026
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown