MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. LEVEL 1 FAST FLOW TRAUMA HIGH FLOW WARMING SET; 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
Additional Manufacturer Narrative
B3.Date of event: month and year of event have been provided, but day is unknown.H4.Device mfg date: the reported lot# 4305709 could not be found for the reported catalog# di-60hl; therefore, the manufacturing date could not be determined.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 reportable information becomes available.
Event or Problem Description
It was reported that liquid leaked from the gray tip.This occurred during patient use/administration.There was patient involvement, and no patient harm/adverse event reported.
Additional Manufacturer Narrative
Investigation summary: the affected device was returned for evaluation.The customer provides one photo.The image only shows a di-60 set and is not possible to identify the failure mode reported in the complaint.According to the visual inspection the failure mode reported in the complaint was not confirmed.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.
Additional Manufacturer Narrative
One device was returned for analysis.Functional and visual tests were done, but the reported issue could not be duplicated.The cause of the issue could not be identified.The heat exchanger assembly was successfully installed.No leakage was observed.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.

• Brand Name: LEVEL 1 FAST FLOW TRAUMA HIGH FLOW WARMING SET
• 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 ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19939476
• Report Number: 9617604-2024-00635
• Device Sequence Number: 18000320
• Product Code: KZL
• UDI-Device Identifier: 20695085406010
• UDI-Public: (01)20695085406010(17)260705(10)4305709
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/15/2025

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: 07/05/2026
• Device Catalogue Number: DI-60HL
• Device Lot Number: 4305709
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/29/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2024
• Supplement Date Received by Manufacturer: 09/02/2024; 09/25/2025
• Initial Report FDA Received Date: 08/08/2024
• Supplement Report FDA Received Date: 09/24/2024; 10/15/2025
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown