MAUDE Adverse Event Report: ICU MEDICAL, INC. CADD-SOLIS HPCA AMBULATORY INFUSION 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	03/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspected product was returned for analysis.The event history log was not reviewed, as the unit was not serviced during the relevant period.A visual inspection was conducted.The customer-reported issue of a failed air-in-line (ail) test was verified and further confirmed through the air detector test.The aild was replaced, followed by a successful air detector test, dso/uso sensor calibration, and additional performance checks.The unit met all testing criteria.Further inspection identified additional issues, including a rusted battery door, a buckled uso seal, a delaminated dso seal, and a scratched lens.The uso seal, dso seal, battery door, and lens were replaced.Subsequently, dso/uso sensor calibration and product verification testing (pvt) were performed.The unit successfully passed all testing criteria.
Event or Problem Description
It was reported that the device had failed air in line sensor issue.There was no reported patient involvement.

• Brand Name: CADD-SOLIS HPCA AMBULATORY INFUSION 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 north,; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 25449302
• Report Number: 3012307300-2026-05880
• Device Sequence Number: 9510606
• Product Code: MEA
• UDI-Device Identifier: 10610586038778
• UDI-Public: (01)10610586038778(11)160111
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K130394
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 06/09/2026

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: 21-2111-0300-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2026
• Initial Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown