CONCORD MANUFACTURING LIBERTY SELECT CYCLER ASSY(NON-VALUATED); SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
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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 05/29/2018 |
Event Type
malfunction
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Manufacturer Narrative
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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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Event Description
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During routine follow up on a peritoneal dialysis patient customer experience, the patient¿s peritoneal dialysis nurse reported that the patient encountered an overfill with the liberty select.Treatment data was 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 (manual stat drain) where 4500ml 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 fill volume 2100ml is 3780ml.Therefore, a reportable malfunction has occurred.The patient did not experience any complications and there was no medical intervention.The patient continued using the cycler for treatments.
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Search Alerts/Recalls
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