A review of the device history record (dhr) was conducted which confirmed that the product met all quality criteria and manufacturing specifications prior to release.There is no information to indicate that a malfunction occurred.The instructions for use warn that the device must be used under the prescription of a physician.The nxstage user guide and instructions for use include allergic reaction as a potential risk associated with dialysis therapy and also include warnings to monitor for potential allergic reactions.The patient¿s blood pressure, vital signs, general well-being, and physical status should be monitored closely throughout the treatment.Biocompatability has been established.
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A report was received on (b)(6) 2021 from the nurse of a (b)(6) old female in the critical care unit status post cardiac arrest with cardiogenic shock including hypotension requiring vasoactive medications, who stated the patient experienced tachycardia and hypotension approximately five minutes into their first continuous renal replacement therapy (crrt) session on (b)(6) 2021.Additional information was received on 12 jan 2021 from the nurse who stated the patient also desaturated, with oxygen (o2) levels decreasing from 99-100% to 40-60%.Symptoms improved with administration of 1 mg intravenous epinephrine, sodium bicarbonate (dose not provided) and 100% fio2.The patient was rechallenged with the device later that day, after being premedicated with intravenous diphenhydramine, methylprednisolone and famotidine, doses unspecified and experienced no further reaction.
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