This report is being provided as a result of fda 483 file number 3009763347 observation 1.The details of the patient condition are: per (b)(6) the patient experienced bowel ischemia with unknown relation to hemolung therapy.Awaiting further information.Update: the treating physician feels the likelihood of the hemolung transferring an air embolus or blood clot directly to the bowel is very low.An echo showed no patent forman ovale.The cartridge and catheter were examined post use by the physician and paul turner ans appeared remarkable clean with no evidence of clotting.The patient did die of multi-organ failure post-hemolung use.Tga was notified and the final closure report from tga was received by alung.
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