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 team has 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 device is functioning post treatment.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 about 20 minutes into treatment, the patient complained of feeling hot and coded during dialysis treatment on a tablo device.It was reported that the patient was hemodynamically unstable prior to beginning the dialysis treatment.The treatment was ended and the patient's blood returned successfully.The care personnel initiated cardiopulmonary resuscitation (cpr) and the patient was resuscitated and transferred to the intensive care unit (icu) and noted in stable condition.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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