The alleged event is not confirmed.The device was not returned to the manufacturing plant for investigation.An investigation of the product history records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, the product history review confirmed the labeling, material, and process controls were within specification.
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Peritoneal dialysis nurse reported the peritoneal dialysis patient had a prolonged time of draining of 71 minutes on the liberty select.Patient treatment details was provided and assessed for 150% and 180% iipv and did reveal an episode of increased intraperitoneal volume (iipv).The largest drain volume from this treatment occurred on (b)(6) 2018 during (manual stat drain) where 3900ml drained.This drain is 195% of the prescribed fill volume.In order to be a reportable malfunction, at least 180% of the prescribed fill volume would have to have been drained.A 180% of fill volume 1996ml is 3593ml.Therefore, a reportable malfunction has occurred.Additional information was solicited.
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