MAUDE Adverse Event Report: ICU MEDICAL, INC. CADD MS3 PUMPS; PUMP, INFUSION

Catalog Number	21-7411-51
Medical Device Problem Code	Failure to Infuse (2340)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported the pump did not calibrated correctly.It was reported that on 2 occasions, including (b)(6) 2025, numbness of the hands and feet, dizziness, absence of usual facial flushing with remoduling, and general malaise had been experienced.
Additional Manufacturer Narrative
H3/h6: 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.The service history review identified no indication that the complaint was related to a service of the device within the review period.

• Brand Name: CADD MS3 PUMPS
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): ICU MEDICAL, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 23760771
• Report Number: 3012307300-2025-13332
• Device Sequence Number: 18661795
• Product Code: FRN
• UDI-Device Identifier: 10610586029554
• UDI-Public: (01)10610586029554(11)170224
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K051568
• 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,Followup
• Report Date (Section B): 03/09/2026

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: 21-7411-51
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2025
• Supplement Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/24/2017
• 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 Age: 60 YR
• Patient Sex: Female
• Patient Weight: 113 KG