From the information provided, there is no indication that there was any device malfunction, nonconformance, or misuse that contributed to the reported event.Potential adverse events in the instructions for use (ifu) with the tablo system includes, but are not limited to, other, more serious, complications arising from dialysis, such as hemorrhage, air embolism, acidosis, alkalosis or hemolysis, can cause serious patient injury or death.Outset medical, inc.Technical support specialist (tss) reviewed site system logs with a procedure date of (b)(6) 2020, and verified that there was no issue with the system which caused the patient event.The console is operating as intended after the event.A review of production records for this unit did not note any manufacturing nonconformances that would contribute to a product.
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It was reported that a patient coded and expired during dialysis treatment on a tablo device.It was reported that the patient was a covid-19 positive, was ill and who was intubated.No further information was provided.Per the information received from the customer site, it is not believed that the tablo device was the cause of this event rather this was attributed the patient's pre-existing condition.
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