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

Model Number	2110
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional information becomes available.
Event or Problem Description
It was reported that the pump has a hole and an upstream occlusion.The event occurred while in use with a patient.
Additional Manufacturer Narrative
Device was not returned for analysis.Customer reported pump has a note on it that said upstream occlusion.No event history log provided.Product not returned.No evidence provided for review.No previous repair was noted for the last 12 months.Based on the review of information provided from the customer we are unable to determine a probable cause as the device was not returned for evaluation.Unable to confirm complaint as no device was returned.

• Brand Name: CADD SOLIS HPCA PUMP
• Common Device Name: PUMP, INFUSION, PCA
• Manufacturer (Section D): ICU MEDICAL, INC., OAKDALE MN; 3350 granada avenue north; oakdale MN 55128
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 60045 ; 2247062300
• MDR Report Key: 22236959
• Report Number: 3012307300-2025-07222
• Device Sequence Number: 8026558
• Product Code: MEA
• UDI-Device Identifier: 15019517154887
• UDI-Public: (01)15019517154887(11)230323
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2025

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: Lay User/Patient
• Device Model Number: 2110
• Device Catalogue Number: 21-2111-0402-78
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2025
• Supplement Date Received by Manufacturer: 07/31/2025
• Initial Report FDA Received Date: 06/17/2025
• Supplement Report FDA Received Date: 08/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/23/2023
• 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