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

Model Number	2110
Medical Device Problem Code	False Alarm (1013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the pump was repeatedly showing an occlusion error even though there was no actual occlusion present.Despite checking the tubing, cassette and setup, the error continued to occur frequently.There was unknown patient involvement and unknown patient harm/adverse event reported.
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
H6: codes were added.One device was returned for investigation.It was reported that the pump was repeatedly showing an occlusion error even though there was no actual occlusion present and it was able to be duplicated.The reported issue was determined to be caused by a delaminated dso seal and loss of factory calibration dso data.Problem was resolved after replacement the dso seal and recalibrated dso sensor.Device submitted for functional and delivery tests after repair activities completed afterwards the device shall be returned to the customer once passing results for functional/delivery tests are confirmed.Service history review identified there was no indication that the complaint was related to a service of the device within the review period.

• Brand Name: CADD-SOLIS 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: 24313279
• Report Number: 3012307300-2026-01140
• Device Sequence Number: 4941788
• Product Code: FRN
• UDI-Device Identifier: 10610586041037
• UDI-Public: (01)10610586041037(11)180122
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K111275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2026

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: Health Professional
• Device Model Number: 2110
• Device Catalogue Number: 21-2111-0400-51
• 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: 01/20/2026
• Supplement Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 02/11/2026
• Supplement Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2018
• 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