Address: (b)(6).The device was inspected on site by a technician who observed that the ultrafilter was leaking.Based on past investigations, the most likely failure is a crack in the housing nearby the welding zone.The cause is design related.This issue is being further investigated.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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It was reported that halfway through dialysis treatment with a machine equipped with ultrafilter 9000, the machine alarmed a high venous pressure alarm and the blood color was observed to be black.The treatment was stopped and blood restitution was done.The patient complained of dizziness and discomfort with a drop in blood pressure.Treatment was stopped and a bolus of 400 ml was administered in combination with 40 ml of 50% glucose intravenously as the blood sugar was 3.4 mmol/l.The patient recovered with a stable bp.The patient reported he was doing better, and ultrafiltration was set to 2300ml to continue hemodialysis.No additional information is available.
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