MAUDE Adverse Event Report: ICU MEDICAL, INC. CADD SOLIS HPCA PUMP; PUMP, INFUSION, PCA

Model Number	2110
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: the device was received for evaluation.Service history review identified there was no indication that the complaint was related to a service of the device within the review period.Visual and functional tests were performed, which found a ripped downstream occlusion (dso) seal.The dso seal was replaced to fix the issue.
Event or Problem Description
The device was returned because the battery was not charging on the unit.The results of the investigation found that the device's downstream occlusion (dso) seal was ripped.There was no patient involvement.

• Brand Name: CADD SOLIS HPCA PUMP
• Common Device Name: PUMP, INFUSION, PCA
• Manufacturer (Section D): ICU MEDICAL, INC.; 3350 granada avenue north; oakdale MN 55128
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 25229758
• Report Number: 3012307300-2026-05193
• Device Sequence Number: 14728759
• Product Code: MEA
• UDI-Device Identifier: 15019517101003
• UDI-Public: (01)15019517101003(11)171214
• 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: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 05/20/2026

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: 21-2112-0401-51
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown