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

Model Number	2120
Medical Device Problem Code	Failure to Infuse (2340)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the pump gave error code 42221, 040100.There was no patient involvement.
Additional Manufacturer Narrative
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 information becomes available.
Additional Manufacturer Narrative
D9 - date returned to mfr: 13-apr-2026.D8 - was device serviced by third party: updated.H3 and h6 codes: updated.The suspect pump was returned for evaluation.The event history log (ehl) was reviewed; however, the complaint could not be confirmed due to loss of historical data.A 12-month service history review verified that the device had not been serviced during this period.Visual inspection revealed damage to the downstream occlusion (dso) seal.Functional testing was performed, and no error codes were observed during power-up or recorded in the event history log.The complaint could not be confirmed.The device has data history failure and needs printed wired assembly (pwa) replacement.

• 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: 24776512
• Report Number: 3012307300-2026-03253
• Device Sequence Number: 9935320
• Product Code: FRN
• UDI-Device Identifier: 15019517084368
• UDI-Public: (01)15019517084368(11)171019
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2026

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: Health Professional
• Device Model Number: 2120
• Device Catalogue Number: 21-2120-0103-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2026
• Supplement Date Received by Manufacturer: 05/22/2026
• Initial Report FDA Received Date: 04/03/2026
• Supplement Report FDA Received Date: 06/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown