Plant investigation: the majority of all reported leaks show detachment of the potting compound.Around the world, there are no known problems with the hemoflow f 8 hps; it appears to be a local problem.Review of the instructions for use (ifu) and/or device label determined the described situation is adequately addressed.The complaint sample was not available.The provided picture confirmed 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 performed.St.Wendel dialyzers are 100% tested for leaks, by performing both bubble-point testing and air testing during sterilization.
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