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

Model Number	2110
Medical Device Problem Code	Device Alarm System (1012)
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 during power up the pump experienced error code 41100 is associated with an adc safety signal issue.The pump was connected to a wireless communication module at the time of the fault.The errors only occurred after the communication modules were attached and power was then supplied via the ac adapter before being turned on.There was no patient involvement.
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 not returned for evaluation.Therefore, visual inspection, functional testing, and event history log review could not be performed.A review of the available service history identified no previous related repairs within the last 12 months.The customer complaint pump displayed error code ¿41100¿ could not be confirmed.Based on the information provided and the absence of the device for evaluation, a probable cause could not be determined.

• 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: 50792203
• Report Number: 3012307300-2026-08736
• Device Sequence Number: 9415577
• 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: 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