A report was received on (b)(6) 2018 from a healthcare professional regarding a (b)(6) female with a recent history of myocardial infarction and hypotension during conventional hemodialysis, who became symptomatic during their first short daily hemodialysis treatment using the involved device on (b)(6) 2018.Within ten minutes of commencing treatment, the patient began to feel itchy and had facial flushing with a blood pressure (bp) of 112/80 and heart rate (hr) of 110 beats per minute.An unspecified volume of saline was administered without improvement.The patient experienced additional symptoms including nausea and vomiting, which progressed to unresponsiveness, diaphoresis, lip swelling, fixed pupils and a blood pressure that could not be obtained.A further volume of saline (800ml) was administered with some improvement (bp 117/78, hr 33) and emergency services attended.The patient received two epipen injections, two doses of adrenaline (nos) and was hospitalized.She recovered without sequelae and received hemodialysis with a conventional hemodialysis device from another manufacturer on (b)(6) 2018 without issue.
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