The reported symptom (iipv ((dv > 200% of fv) was not confirmed.The reported symptom balloon valve leak warning was not confirmed.Encountered dc drain complication encountered.There was visual evidence of liquid within pneumatic filter hp1.The hp1 filter was replaced.After replaced the clogged hp1 the simulated treatment was performed, completed without any failures or problems.The cycler weighed fill volume values were within tolerance.The system air leak passed.The voltage check passed.The load cell value and verification was within tolerance.A visual inspection of the returned cycler exterior showed no sign of physical damage.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 patient contact reported during troubleshooting with technical support that the patient experienced high drain volumes.Patient treatment data 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 during drain 4 where 4499ml drained.This drain is 214% 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.180% of the prescribed fill volume of 2106ml is 3791ml.Therefore, a reportable malfunction has occurred.The patient was advised to cancel treatment and to contact the clinic nurse.The liberty cycler was replaced.Additional information was solicited.
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