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

Catalog Number	21-2120-0102-78
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: codes were updated.One device was returned for investigation.The reported complaint was confirmed no cassete attached alarm was duplicated during dso testing.Visual and functional testing was performed.Upon further investigation, it was found that the downstream occlusion (dso) dso being non-reactive and found cassette not attached alarm after attaching the cassette.Review of event log found no relevant information.Review of service history found no service within the last 12 months.Probable cause is dso sensor.
Event or Problem Description
The device evolution identified damaged downstream occlusion sensor.There was no patient involvement.

• Brand Name: CADD SOLIS VIP AMBULATORY INFUSION PUMP
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): ICU MEDICAL, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 23569325
• Report Number: 3012307300-2025-12489
• Device Sequence Number: 15933760
• Product Code: FRN
• UDI-Device Identifier: 10610586042836
• UDI-Public: (01)10610586042836(11)220517
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/17/2025

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: Health Professional
• Device Catalogue Number: 21-2120-0102-78
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2025
• Initial Report FDA Received Date: 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2022
• 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