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

Model Number	7061
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3, h6: 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 during a visit to exchange the cassette, there was a leak due to a crack in the tube, and the medication was not being injected into the patient.The event occurred during use, and the situation was addressed as the patient was complaining of severe pain during the visit.
Additional Manufacturer Narrative
One device was received for evaluation.Visual inspection identified four partial cuts in the tubing of the set.Three of the cuts were stacked up next to each other and the fourth was located further down the tube.The deformation on the tube showed indentation marks around the tube that lead to a tear.The customer reported issue was confirmed, however, the probable cause of the damage was unknown.The lot history was reviewed; no relevant nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: CADD EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL, INC.; ave calidad no. 4, parque; industrial internacional; tijuana 22425 ; MX 22425
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 22211982
• Report Number: 3012307300-2025-07141
• Device Sequence Number: 18179961
• Product Code: FPA
• UDI-Device Identifier: 10610586020445
• UDI-Public: (01)10610586020445(17)291022(10)6061886
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K942046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2025

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 Model Number: 7061
• Device Catalogue Number: 21-7061-24
• Device Lot Number: 6061886
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2025
• Supplement Date Received by Manufacturer: 07/10/2025
• Initial Report FDA Received Date: 06/16/2025
• Supplement Report FDA Received Date: 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2024
• 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