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

Model Number	2110
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The device evaluation noted a crack downstream occlusion seal.It occurred during preventive maintenance.There was no patient involvement.
Additional Manufacturer Narrative
One device was received for evaluation.Visual inspection noted a cracked downstream occlusion seal.The seal was replaced and the device then passed all functional tests.The service history review had no indication that the complaint was related to a service of the device within the review period.

• Brand Name: CADD-SOLIS HPCA PIB 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: 25048255
• Report Number: 3012307300-2026-04427
• Device Sequence Number: 10410895
• Product Code: MEA
• UDI-Device Identifier: 10610586038808
• UDI-Public: (01)10610586038808(11)161121
• Combination Product (Y/N): N
• 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: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 04/30/2026

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: 21-2112-0300-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown