Catalog Number 109651 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Dyspnea (1816); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Dizziness (2194)
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Event Date 03/02/2020 |
Event Type
Injury
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Manufacturer Narrative
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Initial reporter phone number: (b)(6).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 an allergic reaction within half an hour into treatment.Use with one unit of polyflux 14l.The patient manifested with dyspnea, dizziness, itchy skin and coughing.The patient was treated with oxygen and intravenous dexamethasone (5mg).Thirty minutes later, patient symptoms were in remission and the patient was reported to be stable.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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