It was reported that during an lhc diagnostic procedure, an air injection occurred on the first and second injection.It was reported that there was no acd error message indicator from the system.The air embolism was a couple bubbles, the same size as the artery.The patient is reportedly ok with no adverse symptoms caused by the event.It was reported that the patient did receive oxygen.No cine-angiograms are available of the event.
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If follow-up, what type: the injector serial number: (b)(4) was returned to acist and functionally tested and met the pre-established specifications.There was no evidence of device malfunction related to this event based on the data from the analysis of the injector.The consumables used in this case were not returned for evaluation and the lot numbers are not known.No device history record evaluation could be performed.The acist contrast injection system is equipped with an air column detect sensor.The air column detect sensor senses air in the proximal end of the high pressure (injection) tubing.If air is detected in the tubing, all fluid delivery functions are disabled.Per the acist cvi user manual, the air column detect sensor is designed to aid the user in the detection of air columns in the injection line, but it is not designed to replace the vigilance and care required of the operator in visually inspecting for air and clearing air from the entire patient kit and angiographic catheter.The air column detect mechanism is to be used in conjunction with and to complement the user's other procedures for preventing air injections.Based on the testing of the injector, there is no evidence of device malfunction related to this event.The cause of the event is inconclusive.This report is closed.
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