It was reported that approximately one (1) hour after starting hemodialysis (hd) therapy using an ak 96 control unit, the patient experienced fainting, vomiting and shock.The patient weight was 51.1 kg g after (one) 1 hour of treatment indicating an excessive fluid removal of 4.8l from the start weight.The patient was treated with oxygen administration, 2000 ml normal saline, 5 mg dexamethasone, 20 mg of glucose.The patient recovered from the event.No alarm was generated during the treatment.No additional information is available.
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The actual device was evaluated on site by a local hospital engineer.During inspection a loosened tubing that connect the machine to the dialyzer filter that caused the external leak was found.This was repaired and after reconnecting the loosen connector, the machine was back to normal.The cause of the condition could not be determined.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.Should additional relevant information become available, a supplemental report will be submitted.
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