MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. 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	07/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that leakage occurred during priming.This occurred before patient use/during priming.There was no patient involvement, and no patient harm/adverse event reported.
Additional Manufacturer Narrative
Month and year of event have been provided; day is unknown.Three photos were used for the device analysis.During the analysis, a leak was observed in the joint three of the ¿lumen tube to manifold, molded¿.The complaint was confirmed.The cause was a damaged part/assembly.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.
Additional Manufacturer Narrative
This complaint was incorrectly filed under this registration number, please reference mrn 3012307300-2026-03456-00 for details pertinent to this event.H6: codes were updated.One device was returned for investigation.In order to replicate clinical use, the fluid warmer was installed onto a level 1 fluid warmer.The heat exchanger assembly was successfully installed without difficulty, and the fluid warmer displayed no alarms.The infusate line was primed with an icu medical provided syringe, and no leaks were observed.During operation of the fluid warmer, a leak was observed from the blue manifold below the heat exchanger and the tubing.A channel was observed from the tubing-manifold junction.The complaint of leakage can be confirmed.The probable cause is due to a solvent application error at the tubing-manifold junction during manufacturing in tijuana.Visual and functional testing was performed.

• Brand Name: LEVEL 1 DISPOSABLE NORMOTHERMIC IV ADMIN SETS
• Common Device Name: DEVICE, WARMING, BLOOD AND PLASMA
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20237584
• Report Number: 9617604-2024-00713
• Device Sequence Number: 8089681
• Product Code: KZL
• UDI-Device Identifier: 20695085406010
• UDI-Public: (01)20695085406010(17)250824(10)4189915
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2026

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 Expiration Date: 08/24/2025
• Device Catalogue Number: DI-60HL
• Device Lot Number: 4189915
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/05/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2024
• Supplement Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 09/17/2024
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2021
• 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