MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. LEVEL 1 FAST FLOW TRAUMA FLUID WARMER; DEVICE, WARMING, BLOOD AND PLASMA

Catalog Number	DI-100
Medical Device Problem Codes	Collapse (1099); Fluid/Blood Leak (1250); Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/12/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
B2.Date of death: unknown.No information has been provided to date.D4.Primary udi number: the primary di# has been used as the lot/serial information is unknown.H3.Reason device not evaluated by mfg: other; device was not returned to manufacturer.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 spiking the blood tubing was difficult and the device had a low flow rate.There was leaking from the bag around the spike and drip chambers, which had collapsed during infusion.The patient was part of a massive transfusion protocol and had received multiple blood products as well as medications.Though the patient did receive blood and treatment, the patient ultimately passed away.The product that was initially used is still available and does have coagulated blood throughout the tubing which was unable to be flushed.
Additional Manufacturer Narrative
This complaint was incorrectly filed under this registration number, please reference mrn 3012307300-2025-03499-00 for details pertinent to this event.

• Brand Name: LEVEL 1 FAST FLOW TRAUMA FLUID WARMER
• 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: 21294048
• Report Number: 9617604-2025-00084
• Device Sequence Number: 15390162
• Product Code: KZL
• UDI-Device Identifier: 20695085410017
• UDI-Public: (01)20695085410017
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: DI-100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2025
• Supplement Date Received by Manufacturer: 03/12/2025
• Initial Report FDA Received Date: 02/03/2025
• Supplement Report FDA Received Date: 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown