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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It was reported that 20 minutes after starting treatment with a polyflux 210h dialyzer, the patient experienced dyspnea, bronchospasm, respiratory insufficiency/failure.The patient received oxygen, bronchodilators and hydrocortisone (no further details).The treatment was discontinued with blood restitution.It was reported the patient was ¿totally recovered¿ from the event.No additional information is available.
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