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

Model Number	2120
Medical Device Problem Codes	Degraded (1153); Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the pump had a motor service due and a downstream occlusion seal open.Reporter also alleged error code 46440 was beeping.The event occurred during pre-testing.There was no patient involvement.
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.
Additional Manufacturer Narrative
D9 - date returned to mfr: 21-may-2026.H3 and h6 codes: updated.The suspect pump was returned for evaluation.Review of the event history log showed that system fault error 46440 occurred on 14-mar-2026.A review of the past 12 months revealed no prior service history.Visual inspection identified no anomalies.Functional testing was performed; the reported error code 46440 could not be replicated, though the error was confirmed in the event log.The motor and downstream occlusion (dso) seal were replaced.The probable cause was determined to be a motor service-due alarm.After repair, the device successfully passed all functional tests.

• 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 n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 25148891
• Report Number: 3012307300-2026-04849
• Device Sequence Number: 21181280
• Product Code: FRN
• UDI-Device Identifier: 10610586042591
• UDI-Public: (01)10610586042591(11)210428
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2026

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2026
• Supplement Date Received by Manufacturer: 06/15/2026
• Initial Report FDA Received Date: 05/12/2026
• Supplement Report FDA Received Date: 07/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown