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

Catalog Number	21-2120-0105-01
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: one device was received for device analysis.Service history review identified the complaint was not related to a previous service of the device within the review period.Functional testing and visual inspection performed during analysis.The customer reported complaint was confirmed; the downstream occlusion(dso) seal was delaminated.The dso seal was replaced.
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional information becomes available.The device has not been returned to the manufacturer.
Event or Problem Description
It was reported that the downstream occlusion seal ripped and is bubbled.There is 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 ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 24171750
• Report Number: 3012307300-2026-00546
• Device Sequence Number: 10178325
• Product Code: FRN
• UDI-Device Identifier: 15019517149999
• UDI-Public: (01)15019517149999(11)231108
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2026

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 Catalogue Number: 21-2120-0105-01
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/20/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2026
• Supplement Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 01/23/2026
• Supplement Report FDA Received Date: 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2023
• 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