Catalog Number 112465 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abdominal Pain (1685); Hot Flashes/Flushes (2153)
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Event Date 05/17/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).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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Event Description
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It was reported that a patient experienced sweating and abdominal pain while being treated with hemodiafiltration using an polyflux 140h apac dialyzer.During the treatment the patient presented with sweating and abdominal pain likely associated with intradialytic hypotension (idh).The fluid removal was stopped and 50%g-s20ml was static-injected.The patient was under ecg monitoring and the patient's ¿signs¿ were closely monitored.However, symptoms were not alleviated, and the patient was given a static push of 10% calcium glucose 10ml +0.9%ns 40ml, and the hdf treatment was stopped.No additional information is available.
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Manufacturer Narrative
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H10: based on additional information received, the polyflux 140h was determined not to be a factor in the reported adverse event.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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