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

Model Number	2110
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was found during the investigation of a returned pump that the customer complaint regarding the battery being depleted and the pump not charging when plugged in was confirmed through investigation testing.This issue could potentially interrupt therapy, resulting in a delay in therapy while a replacement pump was obtained.There was no patient involvement and no harm was reported.
Additional Manufacturer Narrative
B3 - date of event is unknown.Therefore, the first day of the month of the icu medical awareness date was used.The suspected device was returned for evaluation.The review of event log performed and found the depleted battery multiple alarms in history log.A review of the available service history identified no previous related repairs within the last 12 months.The visual inspection and functional testing.The customer complaint was confirmed due to the depleted battery alarms triggered during testing.The probable cause of the reported issue was unknown.The downstream occlusion (dso) and upstream occlusion (uso) sensors were calibrated.The device passed all functional testing after repair.The software was updated, and the device was reset to its standard configuration.

• 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: 50901027
• Report Number: 3012307300-2026-08979
• Device Sequence Number: 12262407
• Product Code: MEA
• UDI-Device Identifier: 15019517154993
• UDI-Public: (01)15019517154993(11)241022
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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: 21-2112-0402-51
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/14/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown