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 the patient expired a few minutes into a dialysis treatment.The care personnel reported that the patient was very ill prior to the treatment and an attempt was made to resuscitate the patient, but that was unsuccessful.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 to the patient's pre-existing condition.
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