Investigation findings to date indicated the reported malfunction occurred during recirculation and prime (machine set-up), and typically not during dialysis mode.The user visually observed the saline bag refilling with dialysate during circulation.There have been on adverse events associated with the reported issue.As per field service report could not duplicate the saline bag back fill, ran recirculation 3 times.The venous module was replaced for precaution and recalibrated venous pressure and air detector.An investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or nonconformances during the manufacturing process.In addition, the batch record review confirmed the labeling, material, and process controls were within specification.
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