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

Model Number	2120
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that air was present in the line.The medication was infused at a programmed rate of 5.4 ml per hour, with a total programmed volume of 250 ml.The remaining reservoir volume was 1.2 ml, and the volume delivered was 248.85 ml.The air detector was enabled (low sensitivity), and the upstream sensor was also enabled.It was noted that the pump screen still indicated 1.2 ml remaining.Upon observing the air in the line, the pump was immediately stopped.The event occurred while the device was in use with a patient and there was no patient harm.
Additional Manufacturer Narrative
The suspected device was not received for evaluation.The service history review was performed, and it was confirmed that there was no previous repair noted.The complaint could not be confirmed, and a root cause was unable to be determined.A good faith effort was conducted to retrieve the device from the customer.
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 reportable information becomes available.

• 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: 25136895
• Report Number: 3012307300-2026-04808
• Device Sequence Number: 18511588
• Product Code: FRN
• UDI-Device Identifier: 15019517149999
• UDI-Public: (01)15019517149999(11)220624
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 06/15/2026

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: 21-2120-0105-00
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2026
• Supplement Date Received by Manufacturer: 05/21/2026
• Initial Report FDA Received Date: 05/11/2026
• Supplement Report FDA Received Date: 06/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/24/2022
• 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-2421-202
• Patient Sequence Number: 1
• Patient Sex: Unknown