MAUDE Adverse Event Report: ICU MEDICAL, INC. LEVEL 1 DISPOSABLE NORMOTHERMIC IV ADMIN SETS; DEVICE, WARMING, BLOOD AND PLASMA

Catalog Number	DI-60HL
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2025
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.
Event or Problem Description
It was reported that the device exhibited leakage from the tube connection.There was no patient involvement, no patient injury was reported.
Additional Manufacturer Narrative
Received one device for investigation.Visual inspection found no damage; in order to replicate clinical use, the fluid warmer was installed onto a level 1 fluid warmer (model h-1000).The heat exchanger assembly was successfully installed; no leaks were observed during operation (recirculating fluid path only).The infusate line was then primed using an icu medical provided syringe.A leak was observed at the infusate tubing outlet at the bottom of the heat exchanger (location: between item no.17 & 18, from 14).Upon closer inspection under magnification, a channel was observed at the tubing junction.Evidence of a solvent ring on the tubing end, shows evidence indicative of an inconsistent solvent application.A dimensional analysis was done on the o.D.Of the tubing.The tubing measurements met specifications.The complaint of leakage can be confirmed.The probable cause is due to an inconsistent solvent application at the tubing junction.Service history review identified there was no indication that the complaint was related to a service of the device within the review period.

• Brand Name: LEVEL 1 DISPOSABLE NORMOTHERMIC IV ADMIN SETS
• Common Device Name: DEVICE, WARMING, BLOOD AND PLASMA
• 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: 22511306
• Report Number: 3012307300-2025-08370
• Device Sequence Number: 9265012
• Product Code: KZL
• UDI-Device Identifier: 20695085406010
• UDI-Public: (01)20695085406010(17)260309(10)4265090
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: BK860023
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2025

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 Expiration Date: 03/09/2026
• Device Catalogue Number: DI-60HL
• Device Lot Number: 4265090
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2025
• Supplement Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 07/15/2025
• Supplement Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2022
• 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