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 expired during a dialysis treatment on tablo.It was reported that the patient was desaturating, had low blood pressure, was covid positive and was unstable prior to starting treatment.The treating physician stated that the patient would have died with or without dialysis and that the patient was an acute kidney injury (aci) patient who had been treated during this hospitalization previously.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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