Country of complaint: (b)(6).It was reported that the filter holder is detached.All medwatch submissions related to this report are: 9610612-2017-00207, 9610612-2017-00208, 9610612-2017-00209, 9610612-2017-00210, 9610612-2017-00211.
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Investigation: the investigation was carried out visually.All seals are damaged or fallen off.All plates have the same maintenance date, october 2014 at ats in france.Batch history review: the product does not require batch management; a review of the device quality and manufacturing history records is not possible.Conclusion and root cause: based on the information available as well as a result of our investigation the root cause of the failure is most probably related to an insufficient maintenance of the device.Rational: the maintenance of the retention plates has been carried out insufficiently.The silicon inlays are brittle due to normal aging.There is no maintenance instruction for retention plates available.Instead of using glue, the plates should have been replaced.Corrective action: according to sop (b)(4) a capa is not necessary.
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