Visual inspection has been performed and cracks in the temperature sensor were detected.A crack at the ll of the blood inlet connector and cracks at the cap of temperature sensor.Thus the failure could be confirmed.Device history record of the complaint lot has been investigated and no abnormality was found.Moreover, no scrap record for the related material was found.As a corrective action, based on customer complaints, capa (b)(4) was opened.Within the capa, a root cause analysis (rca) was carried out, which identified three probable root causes (material failure, transport damage and method) and actions were identified for each root cause.The action for material failure is checking and verifying the specification of materials of the temperature probe and the luer lock.The action was completed on 2015-08-28 and all records of affected batches available for investigation were found to be within specification.Additionally, user handling was observed by maquet field staff at the institution, and there was no indication that there is a user handling issue at the customer site.All of the failures reported by the customer were detected during use and were not identified upon receipt; therefore there is no indication from customer complaints of damage during packaging or transit.The most probable root cause is an operation or mechanical failure during manufacture resulting from too high torque being applied as the torque values are not specified in the bops.Full further investigation and all other actions and the effectiveness thereof will be carried out as part of the capa investigation.
|