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	11/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer returned the device for not turning on.During device evaluation, a cracked downstream occlusion seal (dso) was found.There was no patient involvement.
Additional Manufacturer Narrative
H3: one device was received for analysis.Service history review found no related history.The customer issue could not be confirmed through functional testing per performance verification tests (pvt).The device turned on with both ac adapter and aa batteries.Upon further investigation the downstream occlusion (dso) seal was found to be cracked.The seal was replaced.A dso calibration plus a performance verification test (pvt) were performed, and the device passed all testing criteria.The device was reset to standard configuration.

• 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 lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 24209341
• Report Number: 3012307300-2026-00680
• Device Sequence Number: 9661873
• Product Code: MEA
• UDI-Device Identifier: 10610586038808
• UDI-Public: (01)10610586038808(11)200131
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/29/2026

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: 12/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2020
• 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