(b)(4).Maquet getinge group is aware of similar complaints from this product.Similar products, showing a similar malfunction, have been tested.We tested the returned filter in our laboratory, following our standard process, on tightness.Therefore, the quart was tested at below water in a water bath and was then pressurized with compressed air (0.3 bar).Due to the air escaping (visible as air bubbles in water) a leakage in the welding cover has been found.The leakage at the connection between cover and filter body can be confirmed.Most possible root cause could be the bad welding between cover and filter body.Since the reported failure did not contribute to a death or serious injury no corrective action is needed.In addition at this time it cannot be concluded that this is an systemic error.This data will be handled through a designated maquet trending process.If a trend occurs, it will be escalated to quality assurance management for review and determination if further investigation is necessary.
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