MAUDE Adverse Event Report: ICU MEDICAL, INC CADD SOLIS COMM MODULE; ACCESSORIES, PUMP, INFUSION

Catalog Number	21-2131-01
Medical Device Problem Codes	Failure to Infuse (2340); Wireless Communication Problem (3283)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2025
Type of Reportable Event	Malfunction
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.The device has not been returned to the manufacturer.
Event or Problem Description
It was reported that the device had experienced an intermittent wireless module connectivity alarm, which was an out-of-box failure during its implementation at the customer's location.The event occurred during bench test at the hospital.
Additional Manufacturer Narrative
D1, d2a, d2b d4: update.H3 and h6 codes: updated.D4: expiration date and h4: manufacture date is unknown; no information is available based on reported lot number.No product was returned.The reported issue cannot be confirmed as no product was returned for investigation.If the product is returned, this complaint will be reopened for further investigation.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.

• Brand Name: CADD SOLIS COMM MODULE
• Common Device Name: ACCESSORIES, PUMP, INFUSION
• Manufacturer (Section D): ICU MEDICAL, INC; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 22611624
• Report Number: 3012307300-2025-08941
• Device Sequence Number: 5384005
• Product Code: MRZ
• UDI-Device Identifier: 15019517173864
• UDI-Public: (01)15019517173864
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K170982
• 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): 06/24/2026

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 Catalogue Number: 21-2131-01
• Device Lot Number: 20033270
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2025
• Supplement Date Received by Manufacturer: 06/08/2026
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 06/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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