MAUDE Adverse Event Report: ICU Medical, Inc. CADD-Solis HPCA Ambulatory Infusion Pump; Pump, Infusion, Pca

Model Number	2110
Medical Device Problem Code	Failure to Infuse (2340)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when putting the cassette, the pump presents the following message: not attached properly or reattach cassette.Pump alarms only when no cassette is attached, and the latch is closed.This is because the fluid ingress causes sensor drift; dso counts are higher than the software expects with no cassette attached, and therefore the pump alarms ¿cassette not attached properly¿.Dso might need calibration.There was no patient involvement or harm.
Additional Manufacturer Narrative
No information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filled as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

• Brand Name: CADD-Solis HPCA Ambulatory Infusion Pump
• Common Device Name: Pump, Infusion, Pca
• Manufacturer (Section D): ICU Medical, Inc.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; +1(224)706-2300
• MDR Report Key: 50192451
• Report Number: 3012307300-2026-07912
• Device Sequence Number: 20358261
• Product Code: MEA
• UDI-Device Identifier: 10610586038778
• UDI-Public: (01)10610586038778(11)150615
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K130394
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2026

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: 2110
• Device Catalogue Number: 21-2111-0300-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/10/2026
• Supplement Report FDA Received Date: 09/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/15/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown