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

Model Number	2120
Medical Device Problem Codes	Failure to Charge (1085); Failure to Infuse (2340)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer returned the product for error code 41786, accompanied by a constant alarm.The device requires a software update to version 1.6 and further evaluation and repair by icu.During device analysis, the error code 41786 was confirmed.There was no patient involvement.
Additional Manufacturer Narrative
H3: one product was received for evaluation.The service history review found no records in the last 12 months.The customer complaint was confirmed through the event history log (ehl) review.It was found that the error code 41786 had occurred in the event log which was related to the coin battery not charged and software needs to be updated to latest version.The device was placed on charge to charge the coin battery and updated software.A uso/dso sensor calibration plus a performance verification test (pvt) were performed, and the device passed all testing criteria.Software was updated, and the device was reset to standard configuration.

• 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 north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 23934508
• Report Number: 3012307300-2025-13930
• Device Sequence Number: 9448155
• Product Code: FRN
• UDI-Device Identifier: 15019517084368
• UDI-Public: (01)15019517084368(11)190916
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Type of Report: Initial
• Report Date (Section B): 12/31/2025

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: 21-2120-0103-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 12/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2019
• 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