MAUDE Adverse Event Report: ICU MEDICAL, INC. CADD MEDICATION CASSETTE; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	21-7308-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2026
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.
Event or Problem Description
It was reported that the cassette exhibited a leakage during use.There was patient involvement, no injury was reported.
Additional Manufacturer Narrative
The suspected device was returned for evaluation.The device was visually inspected and there were no damages.A functional test was performed and the reported issue was confirmed.The cause of the reported issue was unknown.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.

• Brand Name: CADD MEDICATION CASSETTE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL, INC.; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 24663604
• Report Number: 3012307300-2026-02805
• Device Sequence Number: 20094373
• Product Code: FPA
• UDI-Device Identifier: 10610586032370
• UDI-Public: (01)10610586032370(17)300709(10)6132903
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K081156
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2026

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: Lay User/Patient
• Device Catalogue Number: 21-7308-24
• Device Lot Number: 6132903
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/12/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2026
• Supplement Date Received by Manufacturer: 05/06/2026
• Initial Report FDA Received Date: 03/23/2026
• Supplement Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown