Catalog Number 112466 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Dyspnea (1816); Hypersensitivity/Allergic reaction (1907); Sweating (2444)
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Event Date 06/29/2020 |
Event Type
Injury
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Manufacturer Narrative
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Initial reporter facility name: (b)(6) hospital.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 15 minutes after starting treatment with a polyflux 170h dialyzer, the patient experienced ¿sweating all over the body and difficulty breathing¿.It was reported ¿the patient was allergic to the dialyzer¿.Treatment was discontinued, and the patient was given intravenous dexamethasone (5 mg).It was reported the ¿patient is stable now¿.No additional information is available.
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Manufacturer Narrative
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Additional information: 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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