Model Number LIBERTY SELECT CYCLER |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/26/2018 |
Event Type
malfunction
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Manufacturer Narrative
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A supplemental report will be submitted upon completion of the plant¿s investigation.
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Event Description
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Peritoneal dialysis patient reported to technical support concerns regarding high uf results during peritoneal dialysis treatments.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 3 where 3691ml drained.This drain is 184% 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 fill volume 2002ml is 3604ml.Therefore, a reportable malfunction has occurred.The patient was advised to discontinue use of the cycler and to contact the peritoneal dialysis nurse.Additional information was solicited.
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Event Description
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".".
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Manufacturer Narrative
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Plant investigation: the reported complaint symptom (iipv (dv > 180% to 200% of fv) was not confirmed.The reported complaint symptom (scale reading error warning) was not confirmed.A visual inspection of the returned cycler exterior showed no signs of physical damage.An (as-received) simulated treatment was performed and completed without failures.The cycler weighed fill volume values were within tolerance for a liberty cycler.The system air leak test passed.The valve actuation test passed.The load cell verification was within tolerance.There were no discrepancies encountered in the internal inspection of the cycler.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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