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	08/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the pump experienced error code 41100.Error code 41100 is associated with an adc safety signal issue.This error condition is associated with a high-priority alarm and could potentially interrupt therapy if it occurs during patient use.The pump was connected to a wireless communication module at the time of the fault.The event occurred during setup, and the pump was not in use when the error was generated.There was no patient involvement or harm.
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 suspect pump was not returned for evaluation.A review of the 12-month service history was conducted, and no relevant findings were identified.The customer-reported issue could not be confirmed, and the root cause of the reported error condition could not be determined because the device was not returned for analysis and evaluation.

• 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: 50792828
• Report Number: 3012307300-2026-08740
• Device Sequence Number: 10529809
• Product Code: MEA
• UDI-Device Identifier: 15019517154290
• UDI-Public: (01)15019517154290(11)251006
• Combination Product (Y/N): N
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/16/2026

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2026
• Initial Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/06/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown