The device was not returned to the manufacturer for physical evaluation and the failure mode cannot be confirmed.However, an investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or nonconformances during the manufacturing process.Although a temporal association exists between fresenius products and the event of hospitalization, peritonitis and pneumonia; there is no documentation that indicates a causal relationship between fresenius products and stated adverse events.Furthermore, there are no reported allegations against any fresenius products and the events of hospitalization, peritonitis and pneumonia.Unknown course of hospitalization/ treatment for peritonitis and pneumonia event, therefore unable to determine causality.Should additional new information be made available this clinical investigation will be reevaluated.
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