Plant investigation: review of the instructions for use (ifu) and/or device label determined the described situation is adequately addressed.The complaint sample was not available and no meaningful pictures were provided.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 performed.Although st.Wendel dialyzers are 100% tested for leaks (bubble-point testing and air testing during sterilization), leaks due to adverse environmental conditions or mechanical stress during treatment can occur in very few cases.A batch record investigation was performed and all product was found to be conforming to specifications, and released without any discrepancies.A cause for the reported failure mode could not be established.
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