On 11 july 2019, a clinical study sae was reported.Subject (b)(6) is a retrospective patient enrolled in (b)(6).This patient is a (b)(6)-year-old female.The patient had ekos therapy initiated at 16:43 on (b)(6) 2017.She went into pulseless electrical activity (pea) and hypotension at 17:23.Acls was initiated and the patient was placed on ecmo.The event of pea is recorded as resolved by 17:40.On (b)(6) 2017, the patient had some blood in the et tube, graded as mild.It was noted that the blood in et tube occurred after apt treatment was completed and possibly due to from shock to the liver.The patient was extubated on (b)(6) 2017.On (b)(6) 2017, the patient experienced dyspnea and desaturated to 89% on 15l o2.The patient was placed on cpap with immediate relief.The patient was titrated off cpap and was on 14l o2.On (b)(6) 2017, the patient was reintubated.On (b)(6) 2017, the patient's ejection fraction was 35% when it was previously normal.An ivc filter was placed due to heart strain and lle clot burden.The principle investigator classified the relationship of the pea event as definitely related to the procedure.The principle investigator's assessment of the relationship to ekos for all events is marked as unknown.
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