Catalog Number 112466 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Chest Pain (1776); Dyspnea (1816); Hypersensitivity/Allergic reaction (1907)
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Event Date 08/17/2023 |
Event Type
Injury
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Event Description
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It was reported the patient experienced a potential allergic reaction with a polyflux 170h set.Approximately one hour into hemodialysis therapy, the patient experienced chest tightness and difficulty breathing.Treatment was stopped and oxygen therapy was provided.The patient was treated with 5mg of intravenous dexamethasone.After forty minutes the symptoms subsided, and therapy resumed.No further information was available at the time of this report.
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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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Manufacturer Narrative
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H10: 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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