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

Catalog Number	21-2120-0103-01
Medical Device Problem Codes	Peeled/Delaminated (1454); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspected device was returned for evaluation.The event history log (ehl) was reviewed and there were no errors related to the customer complaint.The device was visually inspected and there was a delaminated downstream occlusion seal.Functional and visual tests were performed and the reported issue was confirmed.The cause of the reported issue was unknown.As a result, the device was beyond economic repair for being 10 years or older.The service history review had no indication that the complaint was related to a service of the device within the review period.
Additional Manufacturer Narrative
A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional information becomes available.
Event or Problem Description
It was reported that the pump had dso sensor bubbled and unattached and device also stated, "pump setting and patient data lost" indicating interior battery is has a problem with it, the event occurred during testing.

• Brand Name: CADD SOLIS VIP 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 n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 24858928
• Report Number: 3012307300-2026-03625
• Device Sequence Number: 16071213
• Product Code: FRN
• UDI-Device Identifier: 15019517084368
• UDI-Public: (01)15019517084368(11)181203
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2026

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 Catalogue Number: 21-2120-0103-01
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/06/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2026
• Supplement Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 04/13/2026
• Supplement Report FDA Received Date: 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown