MAUDE Adverse Event Report: ICU MEDICAL, INC. CADD-SOLIS VIP AMBULATORY INFUSION 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	04/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filled as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that the device displays a red error code screen when first turned on, error code 45985.Device also does not make any noise.The event occurred during testing.There was no patient involvement.
Additional Manufacturer Narrative
The suspect pump was returned for evaluation.Visual inspection was performed and was noted that there was an error code '45985' appeared for the damaged battery compartment.The device did not alarm during power up, but all other sound features were functional.The event history log (ehl) was reviewed and was found that there were four occurrences of the same error code.The service history review was performed and confirmed that there were no anomalies related to the device.The allegation made by the complainant was confirmed.The probable root cause of the event was due to a defective printed wiring assembly (pwa) board, and it will be replaced.

• Brand Name: CADD-SOLIS VIP AMBULATORY INFUSION 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: 25085290
• Report Number: 3012307300-2026-04589
• Device Sequence Number: 18750346
• Product Code: FRN
• UDI-Device Identifier: 15019517126600
• UDI-Public: (01)15019517126600(11)190627
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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: Biomedical Engineer
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2026

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 Model Number: 2120
• Device Catalogue Number: 21-2127-0104-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2026
• Supplement Date Received by Manufacturer: 05/08/2026
• Initial Report FDA Received Date: 05/05/2026
• Supplement Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2419-2024 - Z-2421-202
• Patient Sequence Number: 1
• Patient Sex: Unknown