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

Model Number	2120
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect pump was returned for evaluation.Visual inspection was performed and was found that there was a damaged air detector.The event history log (ehl) was reviewed and was confirmed that there were no anomalies noted related to the complaint.The service history review was performed, and it was confirmed that there was no previous repair noted.The allegation made by the complainant was confirmed.The probable root cause of the event was due to a damaged air detector and was then replaced.
Event or Problem Description
The customer initially stated that an ambulatory infusion pump had a latch and lock which failed to work and after investigation it was found that the pump had a damaged air detector which can lead to interruption of therapy.The event occurred during testing.There was no patient involvement or harm.

• 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: 25670782
• Report Number: 3012307300-2026-06739
• Device Sequence Number: 10406629
• Product Code: FRN
• UDI-Device Identifier: 15019517096378
• UDI-Public: (01)15019517096378(11)180128
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/30/2026

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: 21-2120-0103-51
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2026
• Initial Report FDA Received Date: 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown