Additional information : it was reported during follow up that within 3 minutes of starting therapy, the patient experienced a systolic blood pressure drop to 53 mmhg.The patient reportedly lost consciousness and was aspirated.Treatment was terminated with blood return and the patient was treated with vasopressors as well placed on a ventilator.The patient was stabilized and therapy was restarted 2 hours later.The patient's systolic blood pressure dropped once again to 70-80 mmhg.The vasopressor dosage was increased and the patient continued with treatment.The patient outcome was unknown.The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
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