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

Model Number	D-100
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 during transfusion, the tubing began spraying blood on the floor.It was found that the luer lock connection closest to the patient had become disconnected causing the blood to spray on the floor and the registered nurse.No harm was reported to the patient as a result of the issue.
Additional Manufacturer Narrative
No device was received for investigation.Therefore, we are unable to determine the reported complaint.If we receive the device, we will reopen the investigation for further evaluations.

• Brand Name: LEVEL 1 FLUID WARMER IV 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 22425 ; MX 22425
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21048543
• Report Number: 9617604-2024-00963
• Device Sequence Number: 8409638
• Product Code: KZL
• UDI-Device Identifier: 40695085410004
• UDI-Public: (01)40695085410004(17)280516(10)6005480
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2025

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 Model Number: D-100
• Device Catalogue Number: D-100---802
• Device Lot Number: 6005480
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2024
• Supplement Date Received by Manufacturer: 12/05/2024
• Initial Report FDA Received Date: 12/31/2024
• Supplement Report FDA Received Date: 03/04/2025
• 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
• Patient Sex: Unknown