MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1; DEVICE, WARMING. BLOOD AND PLASMA

Model Number	D-300
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A leak was found in the tubing for a rapid infuser after rapid infusion was initiated.The leak was found during infusion at y-junction of the tubing.A new tubing was primed and connected to the infuser after the old tubing was discarded due to the leak.However, a leak was found in the new tubing as well.No harm to the patient was noted except that the patient received cold blood instead of warm blood.Both tubing sets were discarded by staff.The box says that the iv tubing was "helium leak tested" but it still leaked.Our materials manager will be notifying the manufacturer about this defective product.

• Brand Name: LEVEL 1
• Common Device Name: DEVICE, WARMING. BLOOD AND PLASMA
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 21078649
• Report Number: 21078649
• Device Sequence Number: 6765538
• Product Code: KZL
• UDI-Device Identifier: 20695085430008
• UDI-Public: (01)20695085430008(11)230801(17)270801(10)4415068
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/18/2024
• Report Date (Section F): 12/18/2024

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 Model Number: D-300
• Device Catalogue Number: D-300
• Device Lot Number: 4415068
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/06/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/06/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 77 KG
• Date Report Sent to FDA: 12/18/2024