Model Number LIBERTY SELECT CYCLER ASSY(NON-VALUATED) |
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 04/30/2018 |
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 provided treatment details to technical support during troubleshooting alarms on 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 5 where 4634ml drained.This drain is 232% 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 2000ml is 3600ml.Therefore, a reportable malfunction has occurred.The patient was advised to cancel treatment on the cycler and to contact the clinic nurse.The patient indicated that treatment would not be completed.Follow up with the patient¿s peritoneal dialysis nurse indicates that the patient did not experience any complications as a result of the alleged event.The patient has a new peritoneal dialysis nurse reported that the patient¿s treatment would be adjusted with different strengths of peritoneal dialysis solution.
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Manufacturer Narrative
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The reported complaint symptom (scale reading error warning) was not confirmed.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 passed.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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Event Description
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Manufacturer Narrative
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The reported complaint symptom (scale reading error warning) was not confirmed.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 passed.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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Event Description
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Search Alerts/Recalls
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