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

Model Number	2110
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device delivered a bolus earlier than programmed.The pump was set to administer a 20 ml bolus of 0.2% ropivacaine approximately 3.5 hours after start, with a continuous rate of 1 ml/hour.The settings were verified by two nurses before initiation.Upon starting, the pump immediately began delivering the bolus, which was stopped by the registered nurse after approximately 2.5 ml had been infused.When restarted, the bolus did not resume and no settings were changed.No patient harm or adverse event was reported.
Additional Manufacturer Narrative
No product was returned.The reported issue cannot be confirmed as no product was returned for investigation.If the product is returned, this complaint will be reopened for further investigation.

• 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: 50915661
• Report Number: 3012307300-2026-09009
• Device Sequence Number: 14897606
• Product Code: MEA
• UDI-Device Identifier: 15019517154290
• 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
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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: Health Professional
• Device Model Number: 2110
• Device Catalogue Number: 21-2111-0402-51
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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