(b)(4).Maquet cardiopulmonary (b)(4) is aware of similar complaints for this product.Similar products, showing a similar malfunction, have been tested.The tested products had the same leakage at the same position.This could be determined as bonding failure.Visual inspection, tightness test acc.To lv 203 and tightness test with roller pump have been performed.Results: during tightness test acc.To lv 203 the exact position of the leak in the arterial filter between the cover and the housing could be detected (improper ultrasonic welding).During testing with roller pump leakage at quart could also be detected but the exact position was not found during this kind of test.The existing liquid collected at the lowest point of the filter and drained.Most possible root cause could be the bad bonding between cover and filter body.The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process.Due to this no further investigation initiations will be completed at this time.
|