One open sample (circuit) was returned and per visual inspection the melted tubing was confirmed on the expiratory limb of the circuit.Sample was functionally (resistance) tested and no issues were found with the reading, they were found within spec.Unfortunately without lot number available it is not possible to review the batch history record to search for any extraordinary event that could contribute to the defect reported.Two years of complaints were reviewed from (b)(6) 2013 - (b)(6) 2015 and no trend was observed in the last six months.At this time there is not any evidence that confirms that our operative personnel are contributing to this failure.During the manufacturing review no issues were found with the materials, equipment, environment, or design.Based on similar reports it was determined that the most probable cause could be related to a combination of several factors.These factors contributed to creating the excess heat concentrated in the small tube area.This softened or melted the tube wall.These factors are not recommended actions per the circuit¿s intended function.For example covering the circuit with blankets, or tying the limbs together.Another contributing factor could be that the wire retainer was not in its place at the end of the tube.This could occur at the point of use, and are external to the manufacturing facility.Therefore this is not under the control of the manufacturing facility.Our investigation revealed no issues.As a preventive action carefusion recommends following the product label for recommended uses.The cautions state do not use this circuit where gas temperature at the outlet of the humidifier exceeds 68 degrees celsius.Do not use the heater circuit without gas flow.Do not place material on or around the heated wire tubing.Ifu will be provided to the customer along with the investigation findings.
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