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.Field service engineer (fse) 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 36 minutes into dialysis treatment, the treatment was ended due to patient's condition deteriorating that resulted in a code blue (cardiac arrest) being called.There was no blood loss.Treatment was not resumed on the day of, but patient was treated the following day due to the event.It was indicated that the patient was agitated at the start of the treatment.The clinical staff ruled the tablo device out as the cause for the event.
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