E1: initial reporter address: (b)(6)
h10: 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 an alarm-treatment-air foam in blood triggered on a prismaflex hf1400 set.During continuous renal replacement therapy, the machine started to alarm for air even though no air was present in the circuit.Therapy was halted and the nurse attempted to return the blood; however, the nurse was unable to return the circuit of blood.The patient was then disconnected, and circuit lines were clamped to remove from the prismaflex machine.The alarm continued during removal of the filter set saying, ¿patient was still connected¿ and saying, ¿lines were not clamped¿, even though patient was not connected to machine and all clamps on filter set were closed.The nurse had to override the machine to remove the filter set.The lines were re-primed, and all connections were triple verified.As soon as therapy was restarted, air was observed being pulled into the machine at the vascath site.Therapy was again discontinued and the patient was disconnected.The alarm again showed ¿patient was still connected¿ and ¿lines were not clamped¿ even though patient was disconnected, and all lines were clamped.The machine was removed from service.The patient lost 4 circuits of blood at approximately 180ml each.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
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