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

Model Number	2110
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device had downstream occlusions cover damaged.There was no patient involvement.
Additional Manufacturer Narrative
B3: date of event is unknown.The suspected device was returned for evaluation.The event history log (ehl) was reviewed and there are no errors related to the customer complaint.The device was visually inspected and found damaged downstream occlusion (seal).Customer complaint of downstream occlusion seal damaged confirmed through visual inspection.Replaced dso seal to correct the issue.The software was updated and the unit reset to standard configuration.The service history review had no indication that the complaint was related to a service of the device within the review period.The device passed all functional testing after repair.

• Brand Name: CADD SOLIS HPCA PUMPS
• 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 north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 24617488
• Report Number: 3012307300-2026-02519
• Device Sequence Number: 10181755
• Product Code: MEA
• UDI-Device Identifier: 15019517101003
• UDI-Public: (01)15019517101003(11)190615
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 03/17/2026

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: 21-2112-0401-51
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown