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 Codes	Fluid/Blood Leak (1250); Device Ingredient or Reagent Problem (2910)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2025
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.Investigation still in progress.
Event or Problem Description
It was stated that liquid leakage was observed during the circulating.The event occurred before patient use/during priming.There was no reported patient involvement.
Additional Manufacturer Narrative
H2) device evaluation: d3 manufacturing establishment name updated.D4 primary udi number updated.H3, h6: the device was returned for root cause analysis and the investigation findings concluded after visual inspection and functional testing, and the customer problem was duplicated.There was no damage or anomalies observed.The heat exchanger assembly was successfully installed on the fluid warmer device, no leaks were observed during operation with the recirculating fluid path only.The infusate line was then primed using a syringe.A leak was observed at the infusate tubing outlet at the bottom of the heat exchanger.Upon closer inspection under magnification, a channel was observed at the tubing junction.The tubing coverage showed evidence indicative of an inconsistent solvent application.A dimensional analysis was conducted on the tubing and shunt of the heat exchanger.The tubing measurements were found to be within specifications.The cause of the customer reported problem was inconsistent solvent application at the infusate tubing bond.

• 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: 22170982
• Report Number: 3012307300-2025-06772
• Device Sequence Number: 9401527
• Product Code: KZL
• UDI-Device Identifier: 20695085406010
• UDI-Public: (01)20695085406010
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: UNKNOWN
• 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): 08/01/2025

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 Catalogue Number: DI-60HL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2025
• Supplement Date Received by Manufacturer: 07/17/2025
• Initial Report FDA Received Date: 06/09/2025
• Supplement Report FDA Received Date: 08/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown