Prismaflex st150 set has been temporarily approved for use in the us under emergency use authorization eua200704 to deliver crrt to treat patients in an acute care environment during the covid-19 pandemic.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 that during treatment, the extracorporeal blood from two prismaflex st150 sets was not able to be returned to the patient.The nurse called baxter with a self-test code 1 alarm on a prismaflex machine.After troubleshooting, which involved cleaning the access pressure pod, the alarm returned.The blood from the two sets was not able to be returned to the patient.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
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