MAUDE Adverse Event Report: ICU MEDICAL, INC. CADD SOLIS HPCA PUMP; PUMP, INFUSION, PCA

Model Number	2110
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1.Initial reporter phone, (b)(6).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.Functional tests were performed, and complainant allegation ¿the device doesn't identify the cartridge¿ could be replicated.Replaced downstream occlusion (dso) sensor.The probable cause of the reported issue is dso sensor.
Event or Problem Description
It was stated that the pump doesn't identify the cartridge.There was no patient involvement.It was observed during inspection of a returned pump that downstream occlusion sensor was defective.The failure mode was found before patient use.However, if the issue reoccurs during infusion, it will interrupt therapy and potentially affect the patient.

• Brand Name: CADD SOLIS HPCA PUMP
• Common Device Name: PUMP, INFUSION, PCA
• Manufacturer (Section D): ICU MEDICAL, INC.; 3350 granada avenue north; oakdale MN 55128
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 25599497
• Report Number: 3012307300-2026-06334
• Device Sequence Number: 15903117
• Product Code: MEA
• UDI-Device Identifier: 15019517154986
• UDI-Public: (01)15019517154986(11)220321
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/23/2026

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: 21-2111-0402-51L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2026
• Initial Report FDA Received Date: 06/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown