MAUDE Adverse Event Report: ICU Medical, Inc CADD Solis HPCA Pump; Pump, infusion, pca

Model Number	2110
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was found during the investigation of a returned pump that an "air detector too high" was identified in the air detector height-test.This failure condition could potentially interrupt therapy and may stop the pump if it occurs during patient use.There was no patient involvement or harm.
Additional Manufacturer Narrative
The device was returned for evaluation.Device event history and 12-month service history were reviewed, with no related alarms or previous repairs identified.Functional and visual testing was performed, and the reported issue could not be confirmed.A probable cause could not be determined.Following repair and calibration, verify air detector height - fail "air detector too high".Upon further investigation, identified a damaged battery compartment, broken pwa lcd connector, delaminated dso seal, and an improperly positioned air detector.

• Brand Name: CADD Solis HPCA 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: 50855041
• Report Number: 3012307300-2026-08870
• Device Sequence Number: 18622702
• Product Code: MEA
• UDI-Device Identifier: 15019517154290
• UDI-Public: (01)15019517154290(11)220501
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K170982
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

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: 21-2111-0402-51
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/13/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown