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

Model Number	2120
Medical Device Problem Codes	Contamination (1120); Failure to Sense (1559)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that a cassette attachment error occurred as soon as the cassette was attached to the pump.There was no patient involvement.
Additional Manufacturer Narrative
The device was not returned for analysis.Service history identified that no previous repair has been noted in the last 12 months.The event history log was not provided.As the product was not returned, and no photographic evidence was provided to aid in this investigation, a product evaluation and problem confirmation cannot be performed.Therefore, this investigation was unable to determine a probable cause.
Additional Manufacturer Narrative
D3: mfg establishment name; icu medical, inc.D9: date returned to mfg; 10/9/2025.Device evaluation: one device was received for device analysis.Service history review identified the complaint was not related to a previous service of the device within the review period.Functional testing and visual inspection performed during analysis.The customer reported complaint was confirmed.The probable root cause is due to contamination found on the downstream occlusion(dso) sensor.The dso sensor was replaced.

• 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: 22089309
• Report Number: 3012307300-2025-06209
• Device Sequence Number: 6926624
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/24/2025

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 Model Number: 2120
• Device Catalogue Number: 21-2120-0102-78
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2025
• Supplement Date Received by Manufacturer: 08/04/2025; 11/11/2025
• Initial Report FDA Received Date: 05/27/2025
• Supplement Report FDA Received Date: 08/20/2025; 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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