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 (b)(6) 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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It was reported that a dialyzer blood leak occurred while using an f60s from batch z1bg05100.At the beginning of the treatment, the dialysate port appeared pinkish red.The blood pump was immediately stopped, the dialyzer was replaced, and the treatment was continued.The complaint sample was not available.The estimated blood loss (ebl) volume is unknown.No additional information could be obtained.
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