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

Model Number	2110
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the pump randomly shut off and went into manual mode during testing.During investigation found the damaged air detector which needed replacement.This malfunction makes the event reportable.There are no patient involvement and adverse event reported.
Additional Manufacturer Narrative
The device was initially received with a complaint that the pump intermittently shut off and switched to manual mode during testing.During the investigation, a damaged air detector was identified.This malfunction renders the event reportable.Review of the event log and alarm history could not be completed due to a non-functional usb (universal serial bus) port.Additionally, no 12-month service history was available.Visual inspection confirmed the presence of a damaged air detector.Functional testing was conducted, during which the motor test failed due to the inability to retrieve motor odometer information.The probable root cause of the issue was determined to be the damaged air detector.The allegation reported by the complainant was confirmed.Due to the extent of the damage and the parts required for repair, the device has been deemed beyond economical repair.

• Brand Name: CADD-SOLIS HPCA AMBULATORY INFUSION 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: 25382292
• Report Number: 3012307300-2026-05685
• Device Sequence Number: 13062536
• Product Code: MEA
• UDI-Device Identifier: 10610586038778
• UDI-Public: (01)10610586038778(11)160115
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/04/2026

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: Other
• Device Model Number: 2110
• Device Catalogue Number: 21-2111-0300-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown