A report was received on (b)(6) 2018 from a physician regarding a (b)(6) female patient with a history of heart failure (nos) who was found unconsciousness (time unconscious and time into treatment before losing consciousness unknown) during a standard home hemodialysis treatment on (b)(6) 2018.Blood loss of approximately 250-500 ml was found leaking from the unclamped heparin line.The patient was admitted to the intensive care unit (icu) and hospitalized from (b)(6) 2018 with a hemoglobin of 6.7 g/dl and hematocrit of 0.209.Treatment included volume support (nos) without blood transfusion or use of vasopressors.The physician stated the reported event was due to a use issue, as the patient did not clamp the heparin line, or secure the caps.The patient recovered without sequelae and continues to treat using nxstage products and therapy at a dialysis facility.
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