MAUDE Adverse Event Report: ICU MEDICAL, INC. CADD SOLIS HPCA 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	11/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device gave error code 41622 and red screen while priming.
Additional Manufacturer Narrative
A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Additional Manufacturer Narrative
H3/h6: the suspect pump was returned for evaluation.No issues were found in the event history log (ehl).Service history identified that no previous repair has been noted in the past 12 months.The visual and functional testing was performed.The cause of the reported issue was due to faulty optical sensor.The optical sensor was replaced.The device passed all functional testing after repair.

• 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 ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 23730391
• Report Number: 3012307300-2025-13216
• Device Sequence Number: 9722927
• Product Code: MEA
• UDI-Device Identifier: 10610586029554
• UDI-Public: (01)10610586029554(11)141204
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2025

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: 21-2111-0402-51
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/14/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2025
• Supplement Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 12/05/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown