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 event.
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It was reported that a patient coded (cardiac arrest) during dialysis treatment.The care personnel initiated cardiopulmonary resuscitation (cpr) and the patient was revived.Prior to dialysis treatment, the patient was in critical condition.Per the information received from the customer site, it is not believed that this event was related to a tablo device rather, this event is related to the patient's pre-existing condition.
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