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) reviewed site system logs with a procedure date of (b)(6) 2020, it is believed that the unit functioned as intended by triggering several alarms for low systolic blood pressure.The log review also confirmed that the alarms were cleared by the user.The console is operating as intended after the event.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 went into respiratory failure approximately one hour into dialysis treatment on a tablo device.It was reported that the patient's vital signs were unstable prior to and during treatment; therefore treatment was ended.No further information was provided.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 the patient's pre-existing condition.
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