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

Model Number	2120
Medical Device Problem Codes	Defective Alarm (1014); Complete Blockage (1094); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was initially received for the complaint that the device was beeping in occlusion with no reason and the customer had to remove the battery to turn it off.During investigation found the found damaged dso seal.This malfunction makes the event reportable.Review of event log/alarm history found no event history related to the current complaint.There was no 12-month service history reported.The visual and functional testing was performed.The visual test was performed and found damaged dso seal and got replaced.The primary problem was the defective dso sensor and was replaced.After the repair the device must pass all functional tests before it will be shipped back to the customer.
Event or Problem Description
It was stated that the device was beeping in occlusion with no reason and the customer had to remove the battery to turn it off.During investigation found the found damaged dso seal.This malfunction makes the event reportable.There was no patient involvement.

• 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 north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 24383192
• Report Number: 3012307300-2026-01442
• Device Sequence Number: 10208265
• Product Code: FRN
• UDI-Device Identifier: 10610586042591
• UDI-Public: (01)10610586042591(11)150527
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K111275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/18/2026

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2024
• Initial Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2015
• 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