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 nonconformance's that would contribute to a product.
|
It was reported that a patient coded approximately 40 minutes into a dialysis treatment.The patient was admitted for acute kidney injury (aki) secondary to covid-19 and became agitated, tachycardic, tachypneic and hypotensive shortly into the treatment.The care personnel gave the patient saline boluses and the patient's blood was successfully returned.The patient was intubated and put on vasopressor; however, the patient's family decided to withdraw all treatments, and the patient expired.Note: the patient was reported to be unstable and coded two days prior the treatment.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.
|