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) 2021, 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 a patient, who was in the intensive care unit (icu), coded and expired during dialysis treatment on tablo.It was reported that with approximately 21 minutes left of the dialysis the treatment, the care personnel decided to return the patient's blood and the patient became non-responsive during return of blood and rapidly declined.The estimated blood loss was 300 ml.The patient had a do-not-resuscitate order (dnr) order and care personnel did not provide any further life saving measures.To note, it was reported that the patient's permanent catheter access was not working for her.Per the information received from the customer site, the patient death was unrelated to the tablo device, rather they attributed it to the patient's pre-existing condition.
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