Catalog Number 103579 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Nausea (1970); Palpitations (2467)
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Event Date 06/15/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Should additional relevant information become available, a supplemental report will be submitted.
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Event Description
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It was reported that after 10 minutes of starting treatment with a polyflux 170h dialyzer, the patient experienced shortness of breath, palpitations and nausea.Treatment was discontinued.It was reported the patient¿s ¿symptoms settled after 10-15 minutes¿.There was no report of any medical intervention associated with this event.It was reported this was a first time use with the polyflux dialyzer.No additional information is available.
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Manufacturer Narrative
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A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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