Model Number ASSY(NON-VALUATED) |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problems
Nausea (1970); Discomfort (2330)
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Event Date 05/04/2018 |
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 contact requested a replacement liberty select cycler.The patient has been feeling nausea and shaking and performed a stat drain at the clinic and drained approximately 4000ml of fluid.The additional drain volume and patient¿s 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 5, 1289ml (plus manual stat drain of 4000ml) where 5289ml drained.This drain is 240% 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.The 180% of fill volume 2206ml is 3971ml.Therefore, a reportable malfunction has occurred.Follow up with the patient¿s peritoneal dialysis nurse indicates that there was no medical intervention and that the patient felt some discomfort.The patient has resumed treatments on the replacement cycler.
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Event Description
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".".
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Manufacturer Narrative
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The reported complaint symptom (dv > 200% of fv) 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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Search Alerts/Recalls
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