MAUDE Adverse Event Report: ICU Medical, Inc. CADD Solis HPCA 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	09/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the pump displayed a "cassette was not attached properly" error.Patient involvement associated with this event is unknown.However, if the issue were to recur during an infusion, the pump may not function as intended and could result in an interruption of therapy.
Additional Manufacturer Narrative
B3 ¿ date of event: the exact date of the event is unknown; therefore, the first day based on the icu medical awareness date was entered as the event date.The suspected device was returned for evaluation.There was no 12-month service history during the review.Visual inspection had been carried out, and no anomalies were observed related to the complaint.Functional tests were performed, and complainant allegation could be confirmed and replicated.Replaced downstream occlusion (dso) sensor.The probable cause of the reported issue is defective dso sensor.The device passed all functional testing after repair.

• 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: 50898422
• Report Number: 3012307300-2026-08973
• Device Sequence Number: 18819332
• Product Code: MEA
• UDI-Device Identifier: 15019517154290
• UDI-Public: (01)15019517154290(11)220604
• Combination Product (Y/N): N
• Initial Reporter State: NA
• Initial Reporter Country: AS
• 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: Foreign,User Facility
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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: 09/02/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown