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.Product engineer has reviewed site system logs with a procedure date of (b)(6) 2020.No related system alarms were found to have occurred during treatment.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 event.
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It was reported that during dialysis treatment, the patient had a cerebrovascular accident (cva) after 40 minutes of intermittent hemodialysis (ihd) treatment on tablo, after a period of time the patient was unresponsive and the nurse returned the patient¿s blood without issue with the tablo system.It was reported that the patient did return to consciousness; however, his condition and respiratory status worsened through the night, and it was decided not to take extraordinary measures.Post treatment, the patient expired at 2:00 am on (b)(6) 2020.The treating team attributed the event to the patient's pre-existing condition.
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