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

Model Number	2110
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the pump did not deliver adequate pain relief to the patient overnight and was reportedly under-infusing.This resulted in a delay in therapy.There was no patient harm or adverse event reported.
Additional Manufacturer Narrative
The suspect pump was returned for evaluation.The event history log (ehl) was reviewed, and a review of the 12-month service history was conducted.No relevant findings were identified.Visual inspection and functional testing were performed.The customer-reported issue could not be confirmed through functional testing.The accuracy value of 20.6 was within the specified range of 18.2 to 22.2.Therefore, the device was found to be operating within specifications.

• Brand Name: CADD Solis HPCA Pumps
• 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: 50589229
• Report Number: 3012307300-2026-08484
• Device Sequence Number: 10067851
• Product Code: MEA
• UDI-Device Identifier: 15019517099690
• UDI-Public: (01)15019517099690(11)190806
• Combination Product (Y/N): N
• Initial Reporter State: NA
• Initial Reporter Country: NZ
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/03/2026

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: 21-2111-0401-51
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/17/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown