Plant investigation: the provided picture is most meaningful and best suitable for failure mode decision.The majority of all reported leakages show according to description detachments of potting compound.The following investigation results have been done on basis of all complaint descriptions and due to the fact that all over the world no problems with hemoflow f 8 hps are known, it looks like a local problem.The following investigation tasks have been performed: review of instruction for use (ifu) and/or label evaluation if product deficiency relates to falsification investigation/testing of returned, retained and/or reference samples review of batch documentation review complaint history / trending review of relevant capas.The described situation is adequately addressed in ifu and/or on the label and the product deficiency is not related to falsification.The complaint sample was not available.The provided picture confirms the reported failure.Due to 100% testing, it is highly unlikely to detect a failure in the retention sample.Furthermore, only a small number of reserve samples are available.Therefore the retention sample analysis was not done.The dialyzers are 100% tested for leaks with both bubble-point and air testing during sterilization.
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