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

Model Number	2120
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2026
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that the cadd-solis vip ambulatory infusion pump had a ripped and bubbled downstream occlusion (dso) seal, and the air sensor was found to be detached and falling off.The issue was identified during testing.There were no patient involvement and no patient harm.This may lead to fluid ingress into the pump which will interrupt therapy during infusion if it recurs.

• 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 ; +1(224)706-2300
• MDR Report Key: 25664788
• Report Number: 3012307300-2026-06664
• Device Sequence Number: 5596711
• Product Code: FRN
• UDI-Device Identifier: 15019517096378
• UDI-Public: (01)15019517096378(11)171117
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2026

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: 21-2120-0103-51
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/25/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2026
• Supplement Date Received by Manufacturer: 08/19/2026
• Initial Report FDA Received Date: 06/30/2026
• Supplement Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2419-2024, Z-2421-2024
• Patient Sequence Number: 1
• Patient Sex: Unknown