Model Number SURDIAL-X2-HD-UJ |
Device Problem
Inadequate Ultra Filtration (1656)
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Patient Problem
Weight Changes (2607)
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Event Date 04/21/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The manufacturer evaluated the device in question and determined that the device is similar to 510k# k182940, therefore mdr reportability was detemined on july 8, 2021.
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Event Description
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It was reported that the surdial¿ x dialysis machine removed an excessive amount of fluid during the dialysis treatment.The patient came off the treatment with 0.5 kg under the target weight.The patient was asymptomatic.No further information was provided.
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Event Description
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It was reported that the surdial¿ x dialysis machine removed an excessive amount of fluid during the dialysis treatment.The patient came off the treatment with 0.5kg under the target weight.The patient was asymptomatic.No further information was provided.
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Manufacturer Narrative
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The manufacturer evaluated the device in question and determined that the device is similar to 510k# k182940, therefore mdr reportability was detemined on july 8, 2021.
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Search Alerts/Recalls
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