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	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "when the product was used, it was observed that it was difficult to pass the infusion solution." the event occurred in late feb-2024.This occurred during patient use.No patient harm/adverse event reported.
Additional Manufacturer Narrative
B3: month and year of event have been provided, day is unknown.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.
Additional Manufacturer Narrative
H3 and h6.Investigation codes: updated.Investigation summary: one (1) sample was received for evaluation in a plastic bag without original packaging in used conditions.The complaint sample was visually inspected, at 12¿ to 16¿ under normal conditions of illumination.No damage or other defects were detected on the sample.The sample was assembled in the level 1 system equipment to introduce distillated water and verify the correct functionality of the sample.During the test, a leak was found in union of tube and end cap.The failure mode reported in the complaint is ¿a0350 - occluded/blockage¿, but as a result of the investigation, it is concluded that the correct failure mode was ¿leaking¿.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.

• 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 lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19020851
• Report Number: 9617604-2024-00277
• Device Sequence Number: 3880949
• Product Code: KZL
• UDI-Device Identifier: 20695085406010
• UDI-Public: (01)20695085406010(17)250823(10)4189913
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2024

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: Other
• Device Expiration Date: 08/23/2025
• Device Catalogue Number: DI-60HL
• Device Lot Number: 4189913
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/28/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2024
• Supplement Date Received by Manufacturer: 04/04/2024
• Initial Report FDA Received Date: 04/02/2024
• Supplement Report FDA Received Date: 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2021
• 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