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

Model Number	2120
Medical Device Problem Code	Circuit Failure (1089)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that pump had error code 45169.The event occurred during testing.During investigation found the error code 45169 which was confirmed in event logs.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 displayed error code 45169 during testing.Upon investigation, a defective cpu (central processing unit) pwa (printed wiring assembly) was identified, making the event reportable.The event log and alarm history could not be reviewed because the device could not be initiated into application mode.A 12-month service history was available.Visual and functional testing were conducted.During visual inspection, a dented uso (upstream occlusion) seal was observed.During functional testing, the unit failed the battery fallout test, and the battery fallout alarm produced only a single tone.The probable root cause was identified as a defective pwa, which was replaced; however, the issue persisted.The device has therefore been placed on hold.

• Brand Name: CADD-SOLIS VIP AMBULATORY INFUSION PUMP
• Common Device Name: PUMP, INFUSION
• 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: 25354631
• Report Number: 3012307300-2026-05582
• Device Sequence Number: 10653300
• Product Code: FRN
• UDI-Device Identifier: 15019517126600
• UDI-Public: (01)15019517126600(11)190709
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K111275
• 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): 06/01/2026

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: 2120
• Device Catalogue Number: 21-2127-0104-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2026
• Initial Report FDA Received Date: 06/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown