MAUDE Adverse Event Report: LEVEL 1; WARMER, THERMAL, INFUSION FLUID

Model Number	L-10
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
Information was received indicating that a smiths medical fluid warming accessory found a leakage of medical fluid from the product during a pre-use check.There was no patient present.There were no reported adverse events.
Additional Manufacturer Narrative
Investigation completed on a smiths medical fluid fluid warming|level 1 hotline accessories pictures attached revealed liquid in the filter.Unit received for testing revealed leak in the valve disc.Device passed all functional testing prior to release of product.The event description provided per customer stated: ?during a pre-use check, the customer found leakage of medical fluid from the product, which did not allow him to use it.No patient injury.?after sample evaluation the most probable root cause for the leak condition in valve disc is due to a operator oversight the operation adhesive (loctite 495) in the valve disc, during disc application process, procedure mp l-10 operation 4.7 ?using loctite 495 and efd solvent dispenser (1000series), step on foot pedal to apply single droplet of loctite 495 to center of vent disc seat or ?castle ring? on gas vent body.? was not correctly followed.
Event or Problem Description
Investigation completed and summary.

• Brand Name: LEVEL 1
• Common Device Name: WARMER, THERMAL, INFUSION FLUID
• MDR Report Key: 11691051
• Report Number: 3012307300-2021-03266
• Device Sequence Number: 3515255
• Product Code: LGZ
• UDI-Device Identifier: 40695085401002
• UDI-Public: 40695085401002
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K911383
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2021

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: No Information
• Device Expiration Date: 07/15/2024
• Device Model Number: L-10
• Device Lot Number: 4025990
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/23/2021
• Supplement Date Received by Manufacturer: 07/25/2021
• Initial Report FDA Received Date: 04/19/2021
• Supplement Report FDA Received Date: 08/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2020
• 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