Model Number SURDIAL-X2-HD-UJ |
Device Problem
Inadequate Ultra Filtration (1656)
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Patient Problems
Low Blood Pressure/ Hypotension (1914); Weight Changes (2607)
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Event Date 04/08/2021 |
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 determined on july 8, 2021.
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Event Description
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During dialysis treatment, the machine's ultrafiltration was programmed to take 2.0l off, but instead removed 2.6l.Patient had interdialytic hypotension.Patient's lowest blood pressure was 100/67.No further information was provided.
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Event Description
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During dialysis treatment, the machine's ultrafiltration was programmed to take 2.0l off, but instead removed 2.6l.Patient had interdialytic hypotension.Patient's lowest blood pressure was 100/67.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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