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

Model Number	2110
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for root cause analysis and the investigation findings concluded after visual inspection, functional testing, and event history log (ehl) review, the customer problem was duplicated.The pump was found to have a failing upstream occlusion (uso) sensor.After investigation the results indicated a reportable malfunction due to the failing uso sensor.Service history review identified there was no indication that the complaint was related to a service of the device within the review period.The manufacturer representative replaced the uso sensor, updated software, reset the unit to standard configuration, and performed downstream occlusion (dso)/uso sensor calibration.The pump passed all functional tests and performed as intended after repair.
Event or Problem Description
The customer returned the product for the button port not functioning, and during physical inspection it was found that the upstream occlusion (uso) sensor was failing.After investigation the results indicated a reportable malfunction due to the failing uso sensor.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 north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 22804131
• Report Number: 3012307300-2025-09682
• Device Sequence Number: 8951262
• Product Code: MEA
• UDI-Device Identifier: 10610586039232
• UDI-Public: (01)10610586039232(11)150130
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K072144
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/14/2025

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: 21-2112-0100-51
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2025
• Initial Report FDA Received Date: 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2015
• 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