(b)(4).Maquet cardiopulmonary gmbh requested the products for manufacturer investigation.Both of the purge lines were investigated by laboratory.During the visual inspection of the both lines, a leak was found at the adapter which was between the connection of tube 70105.2890 and tube 70104.9093.The adhesive connections of the tube and adapter were not proper.The failure was confirmed by the laboratory.Device history record of the complained lot has been investigated and no abnormality was found.Moreover, there is no non-conformality and no scar related to similar failure for the claimed materials.The root cause could be related to the gluing failure.However, the exact root cause will be determined according to the capa (b)(4).A sap trend search was performed (search for material 70105.5207) which came to following results: one additional complaint was recorded.An open search of the trackwise complaints database using the material number 70105.5207 was carried out and the searched returned no complaints.Based on the trending for material number, a systemic issue is not indicated.As a corrective action, for the previous complaints regarding to the same failure, we had opened capa (b)(4) and all actions will be followed by capa (b)(4).The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process.If a trend occurs, it will be escalated to quality assurance management for review and determination if further investigation is complaints.Based to this no further investigation initiations will be completed at this time.
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