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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Device evaluation in progress.
Event or Problem Description
It was reported that the gas vent was leaking fluid from the filter.The product problem was observed during patient use.The product fault did not cause or contribute to any adverse patient health effects.
Event or Problem Description
Investigation completed and summary in h10.
Additional Manufacturer Narrative
Other, other text: investigation completed on a smiths medical fluid warming: level 1 hotline accessories with two pictures attached for evaluation.The results from the pictures reveal liquid in the filter.During testing with sample unit, it was discovered leaking detected in valve disc.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.An awareness notification was conducted by the quality engineer to the production personnel in order to avoid the oversight the adhesive operation.

• Brand Name: LEVEL 1
• Common Device Name: WARMER, THERMAL, INFUSION FLUID
• MDR Report Key: 11851444
• Report Number: 3012307300-2021-04647
• Device Sequence Number: 3148723
• 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: company representative,foreig
• 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: Health Professional
• Device Model Number: L-10
• Device Catalogue Number: L-10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/20/2021
• Supplement Date Received by Manufacturer: 07/25/2021
• Initial Report FDA Received Date: 05/19/2021
• Supplement Report FDA Received Date: 08/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• 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