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

Model Number	2110
Medical Device Problem Code	Failure to Infuse (2340)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3 - date of event was unknown, hence captured as first day of icu aware date.The returned pump was evaluated, and the event history log (ehl) was reviewed.It was found that ¿high alarm displayed: cassette not attached properly¿ messages were recorded.A review of the service history indicated that the device had not previously been serviced.The device underwent both visual and functional inspections.During inspection, a broken display glass and a defective dso sensor were identified.The customer¿s reported issue was confirmed, with the probable cause determined to be a defective dso sensor.The issue was addressed by replacing the dso sensor.The device will undergo functional and delivery testing following completion of the repair activities.Once satisfactory results are confirmed, the device will be returned to the customer.
Event or Problem Description
It was reported that the pump did not recognize the cassette, and the issue was identified during annual service.During the investigation, the event history log (ehl) showed alarm messages stating, ¿high alarm displayed: cassette not attached properly.¿ this malfunction makes the event reportable.No patient harm or adverse events were reported.

• Brand Name: CADD-SOLIS 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: 25660132
• Report Number: 3012307300-2026-06657
• Device Sequence Number: 5638520
• Product Code: FRN
• UDI-Device Identifier: 10610586041037
• UDI-Public: (01)10610586041037(11)180306
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/29/2026

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: 2110
• Device Catalogue Number: 21-2111-0400-51
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2026
• Initial Report FDA Received Date: 06/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown