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Catalog Number RTLR180111 |
Device Problems
Use of Device Problem (1670); Overfill (2404)
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Patient Problems
Vomiting (2144); Discomfort (2330)
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Event Date 05/31/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The actual device was returned to the manufacturer for physical evaluation.A visual inspection of the returned cycler exterior showed no sign of physical damage.The simulated treatment was performed and completed without any failures or problems.The cycler weighed fill volume values were within tolerance.Mechanical testing of components all passed.There were no discrepancies encountered in the internal inspection of the cycler.An investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, the device manufacturing review confirmed the labeling, material, and process controls were within specification.
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Event Description
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A peritoneal dialysis patient reported that his cycler was not draining him as expected.The patient reported that during the day he does a manual fill of 2,500 ml.During fill 1 the fill volume was 2,300 ml.The patient was uncomfortable and a stat drain was initiated where the patient drained 6,142 ml.This is 246% of the patient's largest prescribed fill.During the stat drain the patient reported he felt tired and vomited.He did not require any medical intervention.Treatment records were reviewed with technical support and it was discovered that the patient was intentionally bypassing drain 0.The patient reported he was bypassing drain 0 due to a potential misunderstanding of his pd nurse.The reported large drain of 6.142 ml was 246% over the expected drain volume which resulted in a reportable device malfunction.During follow up the patient's nurse reported that the patient did not require any medical intervention and continued dialysis as prescribed with a replacement cycler.
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Search Alerts/Recalls
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